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News about GMP/cGMP


Shortly before the next PIC/S Committee Meeting on 20-21 October 2014 in Paris, the Croatian Agency for Medicinal Products and Medical Devices (HALMED) applied for PIC/S membership.


The use of products with non-declared pharmacological activity or “other illegal medicines”, often from uncontrolled sources but also purchased from the legal market, is still a major problem within Europe.

From 10-11 September 2014, the second symposium on combating counterfeits and other illegal medicines took place at EDQM. Representatives from forensic and customs laboratories, national medicines and food authorities, enforcement groups and the European Commission were invited to shed light on the problem of falsification of medicines.



A comprehensive report of the last ICH meeting, which was held in Minneapolis, MN, USA, on 4-5 June 2014, is now available on the ICH website under the SC Reports page.


According to the Indian financial portal Business Standard and Money Control, the US FDA has started a surprise audit at the Halol Plant of SUN Pharma on Monday 8, 2014.


The Active Pharmaceutical Ingredients Committee, APIC, has recently published a comprehensive How to do Document regarding electronic Common Technical Documents. eCTD is a topic of increasing interest in the pharmaceutical environment. This guideline document focuses entirely on the first submission of an API dossier.


The European Commission has published a revised version of Part II of the EU GMP Guide – Basic Requirements for Active Substances used as Starting Materials. According to the EC this became necessary due to changes in various Annexes of the GMP Guide. Hence Part I can no longer be followed for active substances used as starting materials.


The European Commission has published the final version of the following revised chapters of the EU GMP Guide:

The deadline for implementation is 1 March 2015.


The EU’s decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators PilotExternal link icon (IGDRP). The EU is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the decentralised procedure in real time with collaborating regulatory agencies outside the EU.


Following consultation within the TGA and with relevant stakeholders including Industry and consumer groups, a number of EU/ICH Guidelines have been adopted by the TGA, effective 1 August 2014.


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).

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