To combat counterfeiting of medical products and related crime the Council of Europe has drawn up an international convention – the MEDICRIME Convention – a legally binding instrument criminalising all acts of counterfeiting of medical products. Designed to protect the public health, MEDICRIME introduces criminal sanctions and measures for the protection of the victims. More information is available on the Council's brochure.

Directive 2011/62/EU places an obligation on Member States to take appropriate measures to ensure that manufacturers of active substances on their territory comply with good manufacturing practice ('GMP') for active substances. It also places an obligation on the Commission to adopt, by means of delegated acts, the principles and guidelines of good manufacturing practice for active substances. This concept paper is being released for public consultation with a view to preparing the delegated act on principles and guidelines of good manufacturing practice for active substances in medicinal products for human use. More information is available on the Commission's website.

The European Medicines Agency have published: Regulatory and procedural guideline: Qualification of novel methodologies for drug development: guidance to applicants. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Draft guideline on active-substance-master-file procedure (revision 3), draft: consultation open. This guideline replaces guideline CPMP/QWP/227/02 Rev 2 (EMEA/CVMP/134/02 Rev.2). More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Draft guideline on risk characterisation and assessment of Maximum Residue Limits (MRL) for biocides, draft: consultation open. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Draft VICH GL51: Quality: statistical evaluation of stability data, draft: consultation open. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Draft VICH GL50: Biologicals: testing harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use, draft: consultation open. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Draft VICH GL34: Biologicals: testing for the detection of mycoplasma contamination, draft: consultation open. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: ICH guideline S2 (R1) - Genotoxicity testing and data interpretation for pharmaceuticals intended for human use, adopted. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products, adopted. This guideline provides standard texts for warning statements on transmissible agents to be included in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products. The original guideline (CPMP/BPWG/BWP/561/03) was aopted by CHMP in October 2003 and came into operation in May 2004. This revision affects only the introduction, where an update related to vCJD and an addition concerning albumin as excipient are now included. More information is available on the EMA's website.

Directive 2011/62/EU introduces EU-wide rules for the importation of active substances: According to Article 46b(2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union. The requirement of a written confirmation is waived for third countries listed by the Commission in accordance with Article 111b of Directive 2001/83/EC. Article 111b(2) of Directive 2001/83/EC provides that the Commission adopts an implementing measure to apply these requirements. This concept paper is being rolled out for public consultation with a view to preparing this implementing act. More information is available on the Commission's website.

Directive 2011/62/EU introduces obligatory 'safety features' to allow, inter alia, verification of the authenticity of medicinal products for human use ('unique identifier'). The Directive places the Commission under an obligation to adopt delegated acts setting out the details relating to inter alia the unique identifier. This concept paper is being rolled out for public consultation with a view to preparing both the impact assessment and the delegated act. More information is available on the Commission's website.

The document "Handling of duplicate marketing authorisations applications" has been updated. A new section regarding the classification of the scope of Article 82(1) of Regulation 726/2004 has been included. Prospective applicants are invited to consult the note prior to the submission of applications under Article 82(1). More information is available on the Commission's website.

The European Medicines Agency have published: Scientific guideline: Concept paper on the revision of the guideline on similar biological medicinal product, draft: consultation open. The proposed guideline will replace the guideline on Similar Biological Medicinal Products (CHMP/437/04). More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.7.1, adopted. The objective of CTD Module 2.7.1 is to summarize all relevant information in the MAA dossier with regard to biopharmaceutic studies and associated analytical methods. This Appendix contains a set of template tables to assist applicants in the preparation of Module 2.7.1 providing guidance with regard to data to be presented. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Concept paper on Revising Annex 16 of the Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch Release, draft: consultation open. Annex 16 of the Guide to Good Manufacturing Practice for Medicinal Products gives guidance on the certification and batch release of medicinal products within the European Union and European Economic Area. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Concept paper on the development of toxicological guidance for use in risk identification in the manufacture of different medicinal products in shared facilities, draft: consultation open. The Safety Working Party recommends drafting new guidance on toxicological assessment to be used in the risk identification stage of the Quality Risk Management process in determining whether a medicinal product should be manufactured in dedicated facilities. More information is available on the EMA's website.

The revised proposals amend the original Commission proposals of 2008 and take into account the European Parliament's amendments to the original proposals for legislation on information to patients. More information is available on the Commission's website.

The European Medicines Agency have published: Scientific guideline: Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, draft: consultation open. The proposed guideline will replace the guideline on similar biological medicinal products containing biotechnology derived proteins as active substance: non-clinical and clinical issues: CHMP/BMWP/42832/2005. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Guideline on core SmPC and Package Leaflet for Radiopharmaceuticals, adopted. This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and Package Leaflet for Radiopharmaceuticals. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Guideline on quality of herbal medicinal products / traditional herbal medicinal products, adopted. This guideline concerns the application of Module 3 of Annex I to Directive 2001/83/EC as amended for human herbal medicinal products and Part 2 of Annex I to Directive 2001/82/EC as amended for veterinary herbal medicinal products. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Guideline on specifications test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products / traditional herbal medicinal products, adopted. This guidance document provides general principles on the setting and justification, to the extent possible, of a uniform set of specifications for herbal substances/preparations and herbal medicinal products to support applications for marketing authorisation or registration according to Directives 2001/82/EC and 2001/83/EC as amended. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: VICH GL18(R): Impurities: Residual solvents in new veterinary medicinal products, active substances and excipients (Revision), adopted. More information is available on the EMA's website.

In order to harmonise the performance of the new pharmacovigilance activities introduced by the amended pharmacovigilance legislation (cf. Regulation (EU) No 1235/2010 and Directive 2010/84/EU) the Commission shall adopt several implementing measures. With the public consultation the European Commission intends to describe the scope and content of the implementing measure which it is currently considering and seeks views and feedback from stakeholders on those issues. More information is available on the Commission's website.

The European Medicines Agency have published: Scientific guideline: Reflection paper on the use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in clinical trials, draft: consultation open. As IVR/IWR systems are developed to facilitate overall drug management and expanded to assist with dose titration, unblinding and expiry date update, the intent of the paper is to provide guidance to the sponsors and to the IVR/IWR providers in the use of the systems within clinical trials and detail the expectations of the National Competent Authorities on such systems. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Reflection paper on risk based quality management in clinical trials, draft: consultation open. The aim of this paper is to describe the concept of risk based quality management in the setting of clinical research. Several related approaches have been described that focus on particular aspects of the research. The purpose of this reflection paper is to facilitate the development of a more systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of Good Clinical Practice and to complement existing quality practices, requirements and standards. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Guideline on bioanalytical method validation, adopted. This guideline defines key elements necessary for the validation of bioanalytical methods. The guideline focuses on the validation of the bioanalytical methods generating quantitative concentration data used for pharmacokinetic and toxicokinetic parameter determinations. Guidance and criteria are given on the application of these validated methods in the routine analysis of study samples from animal and human studies. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Guideline on plasma-derived medicinal products, adopted. This guideline provides guidance for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products. Specific attention is given to the virus safety of these products. More information is available on the EMA's website.

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, draft: consultation open. There has been a significant interest to develop drug delivery methods for potent albeit sometimes toxic, highly lipophilic/poorly water soluble, unstable compounds, or for tissue targeting of highly water soluble compounds. One of the strategies has been encapsulation of the active substance(s) in the aqueous phase of a liposome, or incorporation or binding to the lipid components. Liposomes are classically described as vesicles composed of one or more concentric lipidic bi-layers. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Concept paper on the need for revision of the Guideline on non-clinical local tolerance testing of medicinal products, draft: consultation open. Over the past years, newer routes of administration, e.g. transdermal systems, are being used more frequently and a shift has been observed towards the regulatory acceptance of scientifically valid in vitro methods as well as formally validated in vitro methods as part of an integrated testing strategy. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Draft Guideline on stability testing for applications for variations to a marketing authorisation, draft: consultation open. The guideline provides guidance on the stability data which have to be generated in order to support a variation to a Marketing Authorisation. The guideline provides general guidance on stability testing in case of type I (A and B) variations and addresses the data requirements for widely encountered cases of type II variations. More information is available on the EMA's website.

The European Medicines Agency have published: Regulatory and procedural guideline: Compilation of Community procedures on inspections and exchange of information, adopted. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Draft guideline on pharmaceutical development of medicines for paediatric use, draft: consultation open. In January 2007 Regulation EC No 1901/2006 (the “Paediatric Regulation”) entered into force. As a result of this Regulation, the number of paediatric formulations that the pharmaceutical industry will have to develop to support their clinical trials will increase. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Draft template for the Qualified Person’s declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain “the QP declaration template”, draft: consultation closed. The objective of this Qualified Person (QP) Declaration Template is to emphasise the importance of providing a comprehensive declaration, to harmonise the format for the declaration, to forestall questions during assessment, and to enhance the efficiency of the regulatory process. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities), Step 3, draft: consultation open. This guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 – 3.2.S.2.6. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Concept paper on revising chapter 8 of the European Commission guide to good manufacturing practice to introduce risk-based concepts and to provide for more effective investigations and CAPA actions, draft: consultation open. The proposed guideline will replace the current version of chapter 8. More information is available on the EMA's website.

The European Medicines Agency have published: Scientific guideline: Concept paper on the need for a guideline on process validation of medicinal products containing biotechnology-derived proteins as active substance, draft: consultation open. More information is available on the EMA's website.

DG SANCO has launched a public consultation on the revised guidelines for good distribution practices. More information is available at the Commission's website.

Following adoption by the Council and the European Parliament, the new legislation on falsified medicines was published on 1 July in the Official Journal of the European Union. The new legislation will be applicable on 2 January 2013. This legislation is the outcome of the legal proposal that the Commission put forward in December 2008. More information is available at the Commission's website.

The Portuguese Government and the so called “Troika” (including representatives from The European Commission, from The International Monetary Fund – “IMF” and from The European central Bank- “ECB”) have signed a MoU for establishing The General Conditions of Economic Policy within the context of financial assistance from The European Union to Portugal. More information is available on the EIPG website.