GMP News - Regulatory Affairs

11.11.20

WHO Draft Document on GMP for IMPs

In view of recent experiences from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) published a new working document entitled "GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL PRODUCTS".

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28.10.20

Brexit: MHRA updates Guidance

MHRA has issued/ updated a set of guidance documents for UK companies, which will also have impact on EU companies supplying medicines into UK.

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28.10.20

How to Demonstrate GACP-Compliance?

The requirement for a "written GACP declaration" is contained in the current draft of the EMA HMPC Guidance Document "Quality of Herbal Medicinal Products". However, some questions remain: Who creates the declaration and what does it look like?

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21.10.20

MHRA joins Consortium of Regulators - without EU

The British MHRA has joined an Australia-Canada-Singapore-Switzerlan Consortium to explore opportunities for information and work-sharing.

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30.09.20

FDA clarifies "Intended Use"

The U.S. FDA revised the text of their "intended use regulation" to provide additional examples and explanation. In particular clarity is provided by describing examples of types of evidence the agency would consider relevant to determining the intended use of a product. 

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23.09.20

Herbal Medicinal Products: HMPC's Statement on Pyrrolizidine Alkaloids

The Herbal Medicinal Products Committee (HMPC) of the EMA has published the draft of the updated public statement of the HMPC on pyrrolizidine alkaloids (PAs). The document contains, among other things, the limits for the maximum daily intake of PAs.

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14.09.20

Eurasian Pharmacopoeia Available

The Eurasian Economic Commission published Volume 1 of the EAEU Pharmacopoeia. This Volume contains 157 general texts and general monographs.

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14.09.20

Corona: What measures have Governments taken in the Life Sciences Sector?

Governments have been implementing different emergency measures in the fight against the current pandemic. Now an overview of the various measures in the EMEA region has been published.

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09.09.20

Brexit: How to import Medicines into UK

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has just published a Guidance for Wholesaling and Importing Activities after the end of the Transition Period.

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09.09.20

USP publishes draft of new chapter <1220> Analytical Procedure Life Cycle

The USP published the long awaited draft of the new chapter on the Lifecycle of Analytical Methods in the Pharmacopoeal Forum.

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26.08.20

How are FDA Inspections and Applications impacted by COVID-19 Restrictions?

The FDA has published a Q&A document with respect to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products.

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12.08.20

FDA Issues Draft Guidance for Cannabis

The FDA issued a new guideline entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”. The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities than other drug developers.

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06.08.20

EMA Clarifies Investigators Responsibilities Regarding the eCRF

The EMA has updated the Q&As on their Good Clinical Practice (GCP) page. In particular, a new Q&A Nr. 13 clarifies the responsibilities of sponsors and investigators regarding data entered into the eCRF and PI oversight. 

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06.08.20

New Version of the Q&As Applying to Clinical Trials

The European Commission (EC) published an updated Version 2.4 of the Questions & Answers relating to the Clinical Trials Regulation.

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06.08.20

Brexit: Sponsors Need to Establish an EU-QP

Sponsors of EU clinical trials, where the QP is currently located in the UK, need to establish an EU-QP by the end of the transition period. In addition the sponsor of a clinical trial or a legal representative must be established in the EU. Read more here.

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