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News & Press: Regulatory Updates

PHSS Mar 2019 Regulatory Update: Update on the EDQM review of CEP; Established Conditions; Brexit Q&

13 March 2019   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Mar 2019 Regulatory Update available for download for members! Login to view.


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 Australia, the EU and USA regulatory authorities.

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




  • Update on the EDQM review of CEP applications for sartan substances

  • Brexit Q&A Rev 4 (No Deal scenario)

  • EU / USA proposed MRA extension

  • Poland and Slovenia included in EU US MRA

  • Role of big data for evaluation and supervision of medicines in the EU

  • Public statement on contamination of herbal medicinal products with pyrrolizidine alkaloids

  • MHRA Blog Falsified Medicines Directive: Safety Features

  • MHRA - Quality Culture: Learning from History



  • Quality considerations for continuous manufacturing

  • Established Conditions; Pilot Program

  • Public Warning and Notification of Recalls

  • Competitive generic therapies

  • Planning for the effects of high absenteeism to ensure availability of medically necessary drug products

  • CDER’s program for the recognition of voluntary consensus standards related to pharmaceutical quality

  • Evaluation of bulk drug substances nominated for use in compounding under section 503B of the FD&C Act.

  • Guidance documents CBER is planning to publish during calendar year 2019 





  • What is the patient impact of my medicine shortage and do I have to report it to the TGA?

  • Uniform recall procedure for therapeutic goods (URPTG) V2.1

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