Latest News

  • 18.05.2013 The European Commission has published: Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures. More information is available on the Commission's website.


  • 18.05.2013 The European Commission has published: Annual report on benefits and infringements under the Paediatric Regulation. More information is available on the Commission's website.


  • 18.05.2013 The European Commission has published: Eudralex Volume 10 : Clinical Trials - Chapter V Guidance documents applying to clinical trials - Questions & Answers Document, Version 11.0 (May 2013). The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. More information is available on the Commission's website.


  • 18.05.2013 The European Medicines Agency have published: Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 3, draft: consultation open. The purpose of this guideline is to provide a practical framework that can be applied for the identification, categorisation, qualification and control of mutagenic impurities to limit potential carcinogenic risk. This guideline is intended to complement ICH Q3A(R2), 9 Q3B(R2) (note 1), and ICH M3(R2): non-clinical safety studies for the conduct of human clinical trials and marketing authorisations for pharmaceuticals.. More information is available on the EMA's website.


  • 18.05.2013 The European Medicines Agency have published: Regulatory and procedural guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q4B annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests – General chapter - Step 4, adopted. This annex is the result of the Q4B process for the Bacterial Endotoxins Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). More information is available on the EMA's website.


  • 18.05.2013 The European Medicines Agency have published: Regulatory and procedural guideline: EMA/PDCO Standard Paediatric Investigation Plan for Allergen Products for Specific Immunotherapy, adopted. The EU Regulation (EC) No 1901/2006, as amended, on medicinal products for paediatric use (Paediatric Regulation) mandates that any MA application for a new medicinal product should include either the results of studies conducted in compliance with an agreed paediatric investigation plan (PIP), or an EMA decision on a waiver or on a deferral. This document defines a standard set of measures that applicants should include in their application for a PIP. More information is available on the EMA's website.


  • 18.05.2013 The European Medicines Agency have published: Regulatory and procedural guideline: Guideline on the use of the Common Technical Document format in the preparation of a registration application for traditional herbal medicinal products, adopted. This document aims to provide guidance on how to present the application for registration of traditional herbal medicinal products (THMPs) in the Common Technical Document (CTD) format, providing information to help applicants in their submissions. More information is available on the EMA's website.


  • 08.05.2013 The European Medicines Agency have published: Scientific guideline: Draft reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use, draft: consultation open. The European Commission has decided to revise the 'Guideline on excipients in the label and package leaflet of medicinal products for human use (CPMP/463/00 Rev.1)'. A concept paper on the need for such revision has been published in 2012(EMA/CHMP/SWP/888239/2011). Parabens used in medicinal products is one of the priorities among excipients under revision. More information is available on the EMA's website.


  • 08.05.2013 The European Medicines Agency have published: Scientific guideline: Draft guideline on the use of phthalates as excipients in human medicinal products, draft: consultation open. Literature data in animals show that certain phthalates are associated with effects on reproduction and development in relation to their hormonal (anti-androgenic) properties. Currently available human data on the impact of phthalate exposure are limited and therefore the clinical relevance of such findings remains to be established. The most commonly used phthalates in medicinal products licensed in the EU are: dibutyl phthalate (DBP), diethyl phthalate (DEP), polyvinyl acetate phthalate (PVAP), cellulose acetate phthalate (CAP), and hydroxypropyl methylcellulose acetate phthalate (HPMCP). More information is available on the EMA's website.


  • 08.05.2013 The European Commission has published: Template for the qualified person's declaration equivalence to EU GMP for Investigational Medicinal Products manufactured in third countries. More information is available on the Commission's website.


  • 08.05.2013 The European Medicines Agency have published: Regulatory and procedural guideline: Procedural advice on publication of information on withdrawals of applications related to the marketing authorisation of human medicinal products, adopted. More information is available on the EMA's website.


  • 08.05.2013 The European Medicines Agency have published: Regulatory and procedural guideline: Procedural advice on publication of information on negative opinions and refusals of marketing authorisation applications for human medicinal products, adopted. More information is available on the EMA's website.


  • 02.05.2013 The European Medicines Agency have published: Regulatory and procedural guideline: HMPC rules of procedure. More information is available on the EMA's website.


  • 02.05.2013 The European Medicines Agency have published: Scientific guideline: Guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure, adopted. The objective of the guideline is to provide applicants/Marketing Authorisation Holders (MAHs) guidance on the criteria applied by CVMP when reviewing the acceptability of the proposed names for medicinal products processed through the centralised procedure. It provides details on the procedure for checking the acceptability of the proposed names. More information is available on the EMA's website.


  • 02.05.2013 The European Medicines Agency have published: Scientific guideline: Draft guideline on similar biological medicinal products, draft: consultation open. This Guideline outlines the general principles to be applied for similar biological medicinal products (also known as biosimilars) as referred to in Section 4, Part II, Annex I to Directive 2001/83/EC, as amended, where it is stated that ‘the general principles to be applied [for similar biological medicinal products] are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the Agency’. More information is available on the EMA's website.


  • 26.04.2013 The European Medicines Agency have published: Regulatory and procedural guideline: Procedure for orphan-medicinal-product designation: Guidance for sponsors. More information is available on the EMA's website.


  • 26.04.2013 The European Medicines Agency have published: Scientific guideline: Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure - Rev. 2, adopted. Seasonal influenza vaccines for human use authorised via the centralised procedure in accordance with Regulation (EC) No 726/2004, must be varied annually according to Article 18 of Commission Regulation (EC) No 1234/2008 and the Commission “Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 as well as on the documentation to be submitted pursuant to these procedures”. This document describes the specific procedure, timelines and data requirements for the adoption of an opinion of such change(s) by the CHMP. More information is available on the EMA's website.


  • 26.04.2013 The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) have published: E2C(R2) Q&As: Questions & Answers: Periodic Benefit-Risk Evaluation Report. In November 2012, the ICH Steering Committee endorsed the establishment of the IWG on E2C(R2) to assist with the implementation of the new revision (R2) of the E2C Guideline finalised under Step 4 of the ICH Process in November 2012. This revision to E2C has introduced new concepts and principles linked to an evolution of the traditional PSUR from an interval safety report to cumulative benefit-risk report and with a change in focus from individual case reports to more aggregate data evaluation. More information is available on the ICH's website.


  • 26.04.2013 Australia has been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU. More information is available on the Commission's website.


  • 26.04.2013 The European Medicines Agency have published: Scientific guideline: Draft guideline on the compliance of authorised equine influenza vaccines with OIE requirements, draft: consultation open. More information is available on the EMA's website.


  • 26.04.2013 The European Medicines Agency have published: Scientific guideline: Guideline on good pharmacovigilance practices: Annex II – templates: Cover page of Periodic Safety Update Report (PSUR), adopted. More information is available on the EMA's website.


  • 26.04.2013 The European Medicines Agency have published: Scientific guideline: Guideline on good pharmacovigilance practices: Module X – Additional monitoring, adopted. More information is available on the EMA's website.


  • 26.04.2013 The European Medicines Agency have published: Scientific guideline: Guideline on good pharmacovigilance practices: Annex V – Abbreviations. More information is available on the EMA's website.


  • 26.04.2013 The European Medicines Agency have published: Scientific guideline: Guideline on good pharmacovigilance practices: Module VIII addendum I – Member States' requirements for transmission of information on non-interventional post-authorisation safety studies, adopted. More information is available on the EMA's website.


  • 26.04.2013 The European Medicines Agency have published: Scientific guideline: Guideline on good pharmacovigilance practices: Module VII – Periodic safety update report, draft: consultation open. More information is available on the EMA's website.


  • 26.04.2013 The European Medicines Agency have published: Scientific guideline: Guideline on good pharmacovigilance practices: Module VIII – Post-authorisation safety studies, adopted. More information is available on the EMA's website.


  • 24.04.2013 The European Medicines Agency have published: Scientific guideline: Concept paper on extrapolation of efficacy and safety in medicine development, adopted. The concept paper is intended to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation. More information is available on the EMA's website.


  • 23.04.2013 The European Medicines Agency have published: Scientific guideline: Concept paper on assessing the toxicological risk to humans and the environment of veterinary pharmaceuticals in groundwater, draft: consultation open. This intended guideline should provide further technical support to the implementation of the VICH 19 guidelines GL6 and GL38 on the environmental risk assessment (ERA) of veterinary medicinal products (VMPs). More information is available on the EMA's website.


  • 13.04.2013 The European Medicines Agency have published: Scientific guideline: Guideline on good pharmacovigilance practices (GVP): P I - Vaccines for prophylaxis against infectious diseases – Definitions for inclusion in GVP annex I, draft: consultation open. More information is available on the EMA's website.


  • 13.04.2013 The European Medicines Agency have published: Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Product-or population-specific considerations I: Vaccines for prophylaxis against infectious diseases, draft: consultation open. The objective of this module is to strengthen the conduct of pharmacovigilance for vaccines. It should be noted that the overall objectives and processes of pharmacovigilance are no different for vaccines and other types of medicinal products and this guidance does not replace the information provided in the other modules of the good pharmacovigilance practices (GVP). This module focuses on vaccine-specific aspects and unique challenges that should be borne in mind when designing and implementing pharmacovigilance activities for vaccines. More information is available on the EMA's website.


  • 12.04.2013 The European Medicines Agency have published: Scientific guideline: Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file, adopted. More information is available on the EMA's website.


  • 05.04.2013 The European Medicines Agency have published: Regulatory and procedural guideline: Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure. More information is available on the EMA's website.


  • 05.04.2013 The European Medicines Agency have published: Scientific guideline: Concept paper on the need for a reflection paper on quality aspects of medicines for older people, draft: consultation open. Unlike the paediatric case (regulation (EC) No 1901/2006), there is no specific legal requirement for the development of medicines for geriatric use. Nevertheless, there is a need to ensure that medicines are fit for use by patients of all ages within the indicated patient populations. Given the growing older population, the Agency recognizes that it should ensure that the specific needs of the elderly are integrated during the development, approval and use of medicines. More information is available on the EMA's website.


  • 05.04.2013 The European Medicines Agency have published: Scientific guideline: Concept paper on the development of medicinal products for the treatment of autism spectrum disorder, draft: consultation open. Autism spectrum disorders (ASDs) are a group of neurodevelopmental disabilities with symptoms typically presenting before the age of 3 years and persisting into adulthood. They are described as "spectrum disorders" because they affect each person in a variety of different ways and can range from very mild to severe. Delay in language development, impairment of social interaction, and restrictive, stereotyped behaviour patterns are characteristic features. More information is available on the EMA's website.


  • 26.03.2013 The European Medicines Agency have published: Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications. More information is available on the EMA's website.


  • 26.03.2013 The European Medicines Agency have published: Scientific guideline: Reflection paper on Immune Tolerance Induction in haemophilia A patients with inhibitors, adopted. In haemophilia A patients, replacement therapy with factor VIII products has become state of the art. However, a serious complication in the treatment of haemophilia A is the development of neutralizing antibodies against FVIII, causing therapy resistance and increased risk of bleeding. More information is available on the EMA's website.


  • 26.03.2013 The European Medicines Agency have published: Scientific guideline: Draft guideline on the declaration of the quantitative composition / labelling of biological medicinal products that contain modified proteins as active substance, draft: consultation open. More information is available on the EMA's website.


  • 23.03.2013 The European Medicines Agency have published: Regulatory and procedural guideline: Revision of procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure, draft: consultation open. The purpose of this revision is to provide guidance for the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure following amendment of the Variations Regulation (EC) No 1234/2008 by Regulation (EU) No 712/2012. More information is available on the EMA's website.


  • 22.03.2013 The European Medicines Agency have published: Scientific guideline: Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - final, adopted. Development of drug delivery systems to improve disease-specific targeting, to control drug release rates and/or to produce a pharmaceutical formulation suitable for clinical use is desirable. More information is available on the EMA's website.


  • 20.03.2013 The European Medicines Agency have published: Scientific guideline: Draft guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia, draft: consultation open. This guideline describes the information on the clinical development to be documented when an application for a marketing authorisation for a medicinal product is made for the treatment of chronic primary immune thrombocytopenia. The purpose of this guidance is to provide a harmonised regulatory approach that will lead to a consistent assessment of products by regulators and set clear standards for industry. More information is available on the EMA's website.


  • 20.03.2013 Directive 2011/62/EU amending Directive 2001/83/EC on falsified medicines provides the basis of a number of specific implementation measures by the European Commission. An overview of these measures is available on the Commission's website.


  • 20.03.2013 Member States have to transpose Directive 2011/62/EU by 2 January 2013 into national law. An overview of the transpostion status of all Member States, together with a reference to the transposing national law is available on the Commission's website.


  • 19.03.2013 The European Medicines Agency have published: Regulatory and procedural guideline: Practical guidance on the extension of Commission Decision Annexes in the new accession country language, adopted. More information is available on the EMA's website.


  • 16.03.2013 The European Medicines Agency have published: Regulatory and procedural guideline: Implementation plan for the introduction of the new pharmacovigilance legislation requirements into the product information of centrally approved medicinal products. More information is available on the EMA's website.


  • 16.03.2013 The European Medicines Agency have published: Scientific guideline: Draft guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1), draft: consultation open. This guideline replaces Guideline on Modified Release Oral and Transdermal Dosage Forms Section II 9 (Pharmacokinetic and Clinical Evaluation (EMA/CPMP/EWP/280/96 Corr*)). More information is available on the EMA's website.


  • 16.03.2013 The European Medicines Agency have published: Scientific guideline: VICH GL50: Biologicals: harmonization of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use, adopted. Submission of batch safety test data from target or laboratory animals is a requirement for batch release of immunological veterinary medicinal products (IVMPs) in the regions participating in the VICH. More information is available on the EMA's website.


  • 16.03.2013 The European Medicines Agency have published: Scientific guideline: VICH GL51: Quality: statistical evaluation of stability data, adopted. This guideline is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the VICH guideline “GL3(R) Stability Testing of New Veterinary Drug Substances and Medicinal Products” (hereafter referred to as the parent guideline) to propose a retest period or shelf life in a registration application. More information is available on the EMA's website.


  • 16.03.2013 The European Medicines Agency have published: Scientific guideline: VICH GL35: Pharmacovigilance: electronic standards for transfer of data, adopted. The objective of this guideline is to provide standards to construct a single electronic message to transmit GL42 contents to all regions. More information is available on the EMA's website.


  • 16.03.2013 The European Medicines Agency have published: Scientific guideline: VICH GL34: Biologicals: testing for the detection of Mycoplasma contamination, adopted. This VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products) guideline is intended to facilitate the harmonized licensing of new products for veterinary use. More information is available on the EMA's website.


  • 16.03.2013 The European Medicines Agency have published: Scientific guideline: Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - final, adopted. Development of drug delivery systems to improve disease-specific targeting, to control drug release rates and/or to produce a pharmaceutical formulation suitable for clinical use is desirable. More information is available on the EMA's website.


  • 12.03.2013 The European Medicines Agency have published: Scientific guideline: Annexes to: CPMP/ICH/283/95 impurities: guideline for residual solvents & CVMP/VICH/502/99 guideline on impurities: Residual solvents, Annex I: Specifications for class 1 and class 2 residual solvents in active substances, Annex II: Residues of solvents used in the manufacture of finished products , adopted. More information is available on the EMA's website.


  • 09.03.2013 The European Commission has adopted an Implementing Regulation introducing a Black Symbol to identify medicinal products that are subject to additional monitoring. The black symbol will allow patients and healthcare professionals to identify these products, and the accompanying text will encourage them to report unexpected adverse reactions through national reporting systems. More information is available on the Commission's website.


  • 09.03.2013 The European Commission has published the revised Guidelines on Good Distribution Practices of medicinal products in the European Union. The revised guidelines lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain. The guidelines have been published in the Official Journal of the European Union and will enter into force six months from the date of publication. More information is available on the Commission's website.


  • 09.03.2013 The European Medicines Agency have published: Scientific guideline: Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/EC applied to Advanced therapy medicinal products, adopted. The clinical use of Advanced Therapy Medicinal Products (ATMPs) in humans may be associated with specific risks to the patient and to third parties. These risks are determined by various risk factors, which are related to the quality, biological activity and application of the ATMP. More information is available on the EMA's website.


  • 09.03.2013 The European Medicines Agency have published: Scientific guideline: Draft guideline on influenza vaccines – quality module, draft: consultation open. The purpose of this guideline is to provide guidance on development, manufacturing and control for Marketing Authorisation Applications for influenza vaccines. The Quality Module has been updated in the light of experience gained during the recent influenza pandemic and also consolidates the current existing guidelines for influenza vaccines. More information is available on the EMA's website.


  • 07.03.2013 The European Medicines Agency have published: Scientific guideline: Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party, adopted. More information is available on the EMA's website.


  • 07.03.2013 The European Medicines Agency have published: Scientific guideline: Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH), adopted. This guideline lays down the non-clinical and clinical requirements for recombinant human follicle stimulating hormone (r-hFSH)-containing medicinal products claiming to be similar to another one already marketed. More information is available on the EMA's website.


  • 07.03.2013 The European Medicines Agency have published: Scientific guideline: Guideline on similar biological medicinal products containing interferon beta, adopted. This guideline lays down the non-clinical and clinical requirements for interferon beta (IFN-ß) containing medicinal products claiming to be similar to another interferon beta already marketed. The non-clinical section addresses the pharmaco-toxicological requirements and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as pharmacovigilance aspects. More information is available on the EMA's website.


  • 06.03.2013 The European Medicines Agency have published: Scientific guideline: Draft guideline on clinical investigation of medicinal products for the treatment of systemic lupus erythematosus, cutaneous lupus and lupus nephritis, draft: consultation open. This document is intended to provide guidance on the clinical investigation of medicinal products for the treatment of systemic lupus erythematosus (SLE), a complex autoimmune disease that can affect multiple organs. More information is available on the EMA's website.


  • 02.03.2013 The European Medicines Agency have published: Scientific guideline: Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products, draft: consultation open. This guideline describes the information to be considered by the manufacturer of human biological medicinal products using porcine trypsin. More information is available on the EMA's website.


  • 02.03.2013 The European Medicines Agency have published: Scientific guideline: Guideline on the clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy, draft: consultation open. Recent advances in basic and clinical research have opened new perspectives for future therapeutic options in Duchenne and Becker muscular dystrophy (DBMD). The increasing number of clinical trials that recruit a rather small number of patients for these progressive disorders has raised several issues, including the study design, the choice of appropriate efficacy endpoints in general and the definition of reliable surrogate outcome measures 1, 2 as well as the need of subgroup analyses with respect to the heterogeneous patient population and the duration of the trials. More information is available on the EMA's website.


  • 02.03.2013 The European Medicines Agency have published: Scientific guideline: Reflection paper on quality of essential oils as active substances in herbal medicinal products/traditional herbal medicinal products, draft: consultation open. This reflection paper applies to essential oils used as active substances in herbal medicinal products (HMPs) both for human and veterinary use and in traditional herbal medicinal products (THMPs) for human use. More information is available on the EMA's website.


  • 02.03.2013 The European Medicines Agency have published: Scientific guideline: Concept paper on the need for revision of note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure, draft: consultation open. Chronic Heart Failure (CHF) encompasses heterogeneous groups of patients with a wide spectrum of symptoms and different causes. The CHMP Guideline on the clinical investigations of medicinal products for the treatment of cardiac failure (CPMP/EWP/235/95) addresses the development issues in this specific patient population. More information is available on the EMA's website.


  • 02.03.2013 The European Medicines Agency have published: Scientific guideline: Concept paper on use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal products, draft: consultation open. This concept paper concerns the standards to be applied to recycled/recovered solvents used for extraction of herbal substances in the manufacture of herbal preparations for use in herbal medicinal products (HMPs) / traditional herbal medicinal products (THMPs). More information is available on the EMA's website.


  • 02.03.2013 The European Medicines Agency have published: Scientific guideline: Concept paper on the need to revise the guideline on the clinical development of fixed dose combinations of medicinal products regarding dossier content requirements, draft: consultation open. The current guideline CHMP/EWP/240/95 Rev. 1 contains a section describing the legal basis applicable to fixed dose combination (FDC) product marketing authorisation application (MAA). More information is available on the EMA's website.


  • 23.02.2013 The European Medicines Agency have published: Regulatory and procedural guideline: Standard rhabdomyosarcoma paediatric investigation plan, draft: consultation open. The standard paediatric investigation plan (PIP) for rhabdomyosarcoma was prepared by the Paediatric Committee with external experts of the paediatric oncology task force of the European Medicines Agency. The aim is to highlight the persistent unmet therapeutic needs for rhabdomyosarcoma in children, to propose plausible targets and mechanisms of action that could address these needs, to set out the principal features of trials in children with rhabdomyosarcoma and to make the possible requirements for a PIP for rhabdomyosarcoma transparent. More information is available on the EMA's website.


  • 23.02.2013 The European Medicines Agency have published: Regulatory and procedural guideline: Standard acute-myeloid-leukaemia paediatric investigation plan, draft: consultation open. The standard paediatric investigation plan (PIP) for acute myeloid leukaemia (AML) aims to highlight the persistent unmet therapeutic needs for AML in children, to propose plausible targets and mechanisms of action that could address these needs, to set out the principal features of trials in children with AML, and to make the possible requirements for a PIP for AML transparent. The standard PIP is a starting point for discussions on paediatric AML development. More information is available on the EMA's website.


  • 23.02.2013 The European Medicines Agency have published: Scientific guideline: ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 3, draft: consultation open. The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. As a result of chemical synthesis or subsequent degradation, impurities reside in all drug substances and associated drug products. While ICH Q3A(R2): Impurities in New Drug Substances and Q3B(R2): Impurities in New Drug Products (1, 2) provides guidance for qualification and control for the majority of the impurities, limited guidance is provided for those impurities that are DNA reactive. More information is available on the EMA's website.


  • 20.02.2013 The European Medicines Agency have published: Regulatory and procedural guideline: User guide for micro, small and medium-sized enterprises, adopted. More information is available on the EMA's website.


  • 19.02.2013 The European Medicines Agency have published: Scientific guideline: Distant/virtual pharmacovigilance inspections of MAHs during a crisis situation - points to consider, adopted. This document is intended to provide guidance on the steps to be followed during distant / virtual pharmacovigilance (PhV) inspections of MAHs. More information is available on the EMA's website.


  • 19.02.2013 The European Medicines Agency have published: Scientific guideline: Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials, draft: consultation open. This reflection paper has been prepared to bring together the requirements of EU legislation and guidance relating to the TMF . This is deemed necessary by the EU GCP IWG Inspectors due to the numerous questions asked by organisations in relation to the TMF (in particular eTMFs ) and also to the repeated inspection findings concerning the TMF that have been made. More information is available on the EMA's website.