News Archive

New MHRA Blog Post: Remote working and QP certification

26th February 2020

In the modern world it is increasingly common to see flexible, part-time or home working arrangements. Digital connections can allow us to continue to work effectively when we are away from the office. The pharmaceutical industry is no exception, and with some companies employing a part-time or contract Qualified Person (QP), it is no surprise that the QP continues to play a key role even when away from the site.

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Second targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4

20th February 2020

Period of consultation From 20 February 2020 to 20 May 2020. Objective of the consultation Annex 1 was first published in 1971, to ensure sterility of medicinal products placed on the market for the benefits of patients. Since then it has undergone a number of targeted updates but, until now it has not undergone a full review. This revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow.

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EMA - How does EMA support SMEs?

12th February 2020

A new video on how the EMA supports small and medium enterprises.

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EMA Consultation - Reflection Paper on GMP and MAHs

12th February 2020

The European Medicines Agency has released for public consultation the reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders.

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GMDP Symposium, Nov 2019

12th February 2020

The MHRA GMDP Symposium took place on 11 to 14 November 2019 in London and 26 to 27 November 2019 in Glasgow. There will also be a write up in Quasar 151 (April 2020) from the GMP Committee.

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MHRA Guidance Update: Notified bodies for medical devices

5th February 2020

MHRA Guidance Update: Notified bodies for medical devices

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Meeting highlights CHMP, Jan 2020

5th February 2020

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020

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UK withdrawal from the EU on 31 January 2020

31st January 2020

The United Kingdom will formally leave the European Union on 31 January 2020 and will become a third country to the EU. On 1 February 2020 a transition period will start which is due to end on 31 December 2020.

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Pilot programme for international cooperation in GMP inspection of manufacturers of sterile medicinal products for human use

22nd January 2020

Pilot programme for international cooperation in GMP inspection of manufacturers of sterile medicinal products for human use. The purpose of the document is to set out the terms of reference, including objectives, scope, requirements and general principles of an international inspection pilot programme covering manufacturers of sterile medicinal products.

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HMA-EMA Joint Big Data Taskforce Updates

21st January 2020

The HMA and EMA have released more information from their joint 'Big Data Task Force'.

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