Print Page   |   Contact Us   |   Sign In   |   Register
News & Press: Regulatory Updates

PHSS July 2016 Regulatory Update: EMA Statement on the outcome of the UK referendum ; Brexit MHRA

20 July 2016   (0 Comments)
Posted by: Tamsin Marshall
Share |

PHSS July Regulatory Update 2016

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, USA and WHO regulatory authorities.

 

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

Europe

·         EMA Statement on the outcome of the UK referendum

·         Transatlantic Trade and Investment Partnership (TTIP) -EU proposal for an annex on medicinal products

·         EDQM Annual Report

·         Water purified

·         Brexit MHRA position

·         Handling of unexpected deviations- MHRA Blog

USA

·         final guidances on interim policy for certain bulk drug substances used in compounding

·         Quality attribute considerations for chewable tablets

·         Quality metrics technical conformance guide

·         Elemental impurities in drug products

International

WHO

·         Guidance on good data and record management practices

Documents

·         EFPIA annual regulatory GMP/GDP inspection survey


Read more by joining the PHSS, this is a free to members document benefit.


Membership Software Powered by YourMembership  ::  Legal