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News & Press: Regulatory Updates

PHSS Regulatory Update June 2013

29 November 2013  
Posted by: Tamsin Marshall
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PHSS Regulatory Update June 2013


During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the EU, Indian and USA regulatory authorities.

The topics covered in this edition of the "Update” include:


· New Q&As on GMP

· Marketing Authorization Variations

· Importation of Active Substances – current country status listing.

· Revised guideline on biosimilars containing biotechnology-derived proteins

· 146th session of the European Pharmacopoeia Commission

· Changes to information reported on CEPs with regards manufacturing sites

· Introduction of new powers to allow seizure of chemical substances suspected of being used as drug cutting agents(MHRA)

· New tracking system for high-risk medical devices in development


· Guidance for Industry Contract Manufacturing Arrangements for Drugs: Quality Agreements

· Draft Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products

· Guidance for Industry – Co-development of Two or More New Investigational Drugs for Use in Combination

International India

· API Equivalence Listing


· PIP implants (Sweden)

· Nicotine containing products to be regulated as medicines (UK)

Members click here for download of regulatory update

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