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News about GMP/cGMP

2013-09-16

The European Commission has published the final version of the revised Chapter 2 on Personnel. Changes have been made in order to integrate the principles of “Pharmaceutical Quality System” as described in the ICH Q10 tripartite guideline. Furthermore, a section on consultants has been added.

 
2013-08-23

The Falsified Medicines Directive (FMD) has now been transposed into UK legislation and came into force on August 20, 2013. The FMD (Directive 2011/62/EU) introduces a series of measures to prevent the entry of falsified medicines and substandard raw materials into the legal supply chain, including stricter rules on the controls and inspections of producers of active pharmaceutical ingredients (APIs), intensified record-keeping requirements for wholesale distributors, and a common EU-wide logo to identify legal online pharmacies.

 
2013-08-23

FDA is announcing the start of the Secure Supply Chain Pilot Program (SSCPP) in order to assist the Agency in its effort to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the FDA to focus its resources on imported drugs that fall outside the program and may pose risks.

 
2013-08-23

The World Health Organization - supported by the IPEC Federation Member Groups - is currently in the process of revising and updating the „Good Trade and Distribution Practices for Pharmaceutical Starting Materials“ – WHO GTDP guide -  which is open for comments for a restricted audience only until September 2013.

The draft is not to be displayed on any web site and will be presented to the WHO Expert Committee during the 48th meeting in October 2013. Following adoption, the IPEC Federation will update its own guide in line with that of WHO.

Source:

WHO: Current Projects

 
2013-08-14

The ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in July 2013 and now enters the consultation period (Step 3).

 
2013-08-09

The US Food and Drug Administration's (FDA) has announced an initiative in the Center for Drug Evaluation and Research (CDER) involving the review of draft guidance documents issued before 2010. The CDER plans to determine their status, and to decide whether those guidances should be withdrawn, revised, or finalized with only minor changes. The new initiative was published in the latest edition of the Federal Register.

 
2013-08-05

The Australian Therapeutic Goods Administration (TGA), part of the Department of Health and Ageing, has published an outline of its international engagement strategy for the next three years. It links current Australian government priorities for international engagement that are necessary to support effective therapeutic goods regulation with the TGA's business-as-usual activities and sets clear goals for international engagement activities.

 
2013-08-05

The FDA has issued a new guidance for "Safety Labeling Changes — Implementation of Section 505(o)(4) of the FD&C Act”. This section authorizes the FDA to require certain drug and biological product application holders to make safety-related labeling changes based on new safety information that becomes available after approval of the drug or biological product.

 
 
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