GMP NEWS 2014

04.02.2014

New EMA Guidance Qualification of novel Methodologies for Drug Development

The European Medicines Agency EMA has published the revised Guidance to Applicants "Qualification of novel methodologies for drug development". Read more.

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04.02.2014

New FDA Guidance for Drug Development Tools

The FDA has published a new Guidance for Industry and FDA Staff: "Qualification Process for Drug Development Tools". Read more.

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04.02.2014

Health Commissioner welcomes Agreement on the Revision of EU Rules on Clinical Trials

In a memo of the European Commission, Health Commissioner Tonio Borg welcomes the agreement on the revision of EU rules on Clinical Trials. Read more.

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04.02.2014

GCP and Bioequivalence Studies: new FDA/EMA Initiative

The scope of the FDA/EMA initiative on GCP inspections will be expanded to include inspections for generic marketing applications. Read more.

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29.01.2014

85 Company listed with GMP-Non Compliance Statements in the New EMA Database

As already reported, the EMA has started listing so-called GMP Non Compliance Statements in the EudraGMDP database in addition to Certificates of GMP Compliance. Now, detailed information has been made publicly available. Read more in the News.

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29.01.2014

FDA: more Inspections in 2014

With their new budget, FDA will be able to increase drug plant inspections worldwide and especially in China. Read more.

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28.01.2014

"Reception denied!" - the new FDA "Refuse-to-Receive" Guidance for Generics Applications

Errors when compiling an application for authorisation for a generic drug in the United States can be really expensive. It is not only important to ensure the completeness of the documents, but also to pay attention to deadlines with regard to various fees. Learn more here.

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28.01.2014

Update: Electronic Submission of Marketing Authorisation Dossiers

Since the 1st of January 2010, only electronical submissions for marketing authorisations within the centralised procedure can be accepted. A few significant details about the procedure and the standards have been recently changed. Read more here about the current requirements for the electronical submission of dossiers.

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23.01.2014

How to submit an Active Substance Master File?

The Active Substance Master File (ASMF) describes the quality of an API and is an essential document for the marketing authorisation of medicinal products. The procedure to submit an ASMF has been recently updated and described extensively in a new EMA Q&A document. Read more about the newest provisions.

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15.01.2014

FDA 2013 Review: what was achieved

The last year was a difficult year for the FDA and the agency had to suffer from budget restrictions. Despite that, a lot of actions were ongoing. Here is a short summary of some selected activities.

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15.01.2014

Implementation of Good Distribution Practices: Explanatory Notes from MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a document to clarify the interpretation of the new EU Good Distribution Practice (GDP) Guideline. Click here to read more

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15.01.2014

European QP Association: New Q&As published

Besides other publications, the European QP Association (EQPA) regularly issues questions and answers related to the role and responsibilities of the Qualified Person (QP). Now, after the last QP Forum, a new set of Q&As has been published. Read more.

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15.01.2014

Summary of the new EU GMP Chapters and Annexes

The last year was an interesting year for those who have to have an eye on GMP regulations in the European Union. The EU GMP Guide is under constant revision. Here is an overview.

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08.01.2014

EMA now also issues GMP and GDP Non-Compliance Information

So far, EU inspectorates did not publish any results of their inspections. This is changing now. Read more.

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08.01.2014

USP proposal on temperature control during storage and distribution

The USP has published a so called stimuli article which is intended to provide a proposal to revise an existing USP monograph. The proposal intends to broaden the permitted range when appropriate for specific products. Read more in our GMP News

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08.01.2014

GMP for Radiopharmaceuticals - existing and expected Guidelines

Manufacturing of Radiopharmaceuticals includes some specific challenges. To provide additional guidance for these establishments, the PIC/S Committee's new Annex 3 to PE 010-3 is in the final stages for adoption. Read more here.

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