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The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk has reached Step 4 of the ICH process and is now entering the implementation period (Step 5). The final draft isbeing recommended for adoption to the regulatory bodies of the European Union, Japan and the USA.


FDAs Center for Drug Evaluation and Reseach (CDER) has published its yearly list of guidance documents and a list of new, revised and withdrawn guidances. This document provides a concise overview of the status of various guidelines that are currently in process:


Last week the FDA issued several policy documents regarding compounded drug products for human use, as part of the agency’s effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists.


EU regulators have unveiled a new logo which will appear on the websites of all authorised online pharmacies known to provide authentic medicines. This represents one more step towards helping European consumers to avoid counterfeit or falsified medicines.


The Active Pharmaceutical Ingredients Committee (APIC) has recently released two new documents:


The Australian Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the European Directorate for the Quality of Medicines and HealthCare (EDQM).

In May 2014 Australia was accepted as an assessor in the EDQM's procedure for the Certification of Suitability to the monographs of the European Pharmacopoeia (CEPs).


The British authority MHRA have published meeting minutes of their GMP/GDP Consultative Committee that took place on 11th April 2014 in London. Two times a year MHRA meets with different industry groups/associations to inform and discuss about latest GMP and GDP issues. Inter alia, MHRA gave an update on the GMP/GDP documents currently under revision or in preparation, respectively.


EMA has published the long awaited Qualified Person (QP) declaration template and accompanying guidance concerning GMP compliance of API manufacture. The much discussed draft version dates back to 2010.


From 15 to 21 May 2014 the following events took place in Rome (Italy): PIC/S Committee Meeting, PIC/S Executive Bureau Meeting and PIC/S Expert Circle on Active Pharmaceutical Ingredients (APIs).


The FDA, in partnership with other federal and international agencies, took action last week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The Customs and Border Protection (CBP) also conducted extensive investigations at U.S.-based international mail facilities, where many packages containing prescription drugs enter the USA, and found that most of the packages examined contained illegal prescription drugs that had been ordered from online sources.


The PIC/S Committee has adopted a Guide on Good Distribution Practice (GDP), which will enter into force on 1st June 2014. The PIC/S GDP Guide is based on the EU GDP Guide.


The EMA has published a "Questions & Answers Document on the EU framework for (traditional) herbal medicinal products, including those from a non-European tradition".


As previously reported, the FDA is working on a system that will help to identify and trace dangerous drugs that are counterfeit, stolen or tainted throughout the whole supply chain. Together with drug manufacturers, wholesaler distributors, repackers and many dispensers the FDA is working on the development of standards for this new system.


The EMA has published the “Draft guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission”.


With the beginning of this month, the FDA has published the following two updated lists of guidance documents:

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