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News & Press: Regulatory Updates

PHSS Regulatory Update November 2015 :• MHRA signs MOU with its counterpart in India

13 November 2015   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update November 2015


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, WHO and USA regulatory authorities.

Several of the changes in USA regulations relate to the ongoing situation of FDA’s control over compounding pharmacies. In the Product section of this edition we report on yet another instance of lack of sterility assurance of products from one of these pharmacies.

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



  • GMP Q&A supply chain for Active substances
  • Quality of medicines Q&A – variations
  • Annex 16 - Certification by a Qualified Person and batch release
  • Webinar - How to prepare a successful CEP application
  • Electronic application forms (eAFs) mandatory for all medicines licensing from the beginning of 2016
  • MHRA signs Memorandum of Understanding (MOU) with its counterpart body in India.


  • Acceptability of draft labeling to support ANDA approval -guidance for industry
  • Maintenance procedures for the guidance for industry Q3C impurities – residual solvents.
  • Integrated summary of effectiveness-guidance for industry
  • Adverse Event Reporting for Outsourcing Facilities.
  • Pharmacy compounding of human drug products under section 503a of the FD&C Act.
  • Interim policy on compounding using bulk drug substances under section 503A and 503B of the FD&C Act.
  • USP visual inspection of injections
  • USP Pharmacopoeial Forum 41(6) In-Process Revision: <1790>
  • USP <1039> chemometrics In-Process Revision





  • Guidance on good data and record management practice



  • HPV vaccines – EMA review
  • Inductos to be suspended in the EU
  • First oncolytic immunotherapy medicine recommended for approval
  • Drug Products Intended to be Sterile _ Chen Shwezin Inc

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