This website uses cookies to store information on your computer. Some of these cookies are used for visitor analysis, others are essential to making our site function properly and improve the user experience. By using this site, you consent to the placement of these cookies. Click Accept to consent and dismiss this message or Deny to leave this website. Read our Privacy Statement for more.
Print Page   |   Contact Us   |   Sign In   |   Register
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
Share |


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

Membership Software Powered by YourMembership  ::  Legal