Last week’s round -up;
30 November – 04 December 2020

published 7 Dec 2020

Revised Palbociclib and Abiraterone product-specific bioequivalence guidance

The EMA has issued the following product-specific bioequivalence guidance: • A draft bioequivalence guidance for Palbociclib 75 mg, 100 mg and 125 mg hard capsules and 75 mg, 100 mg and 125 mg film-coated tablets. This guidance is open for public consultation until the 28th February 2021. • A newly adopted bioequivalence guidance for Abiraterone tablets 250 mg and 500 mg.

Comments concerning revised texts published in Supplement 10.5

The EDQM has published the technical modifications that have been made to revised texts adopted by the European Pharmacopoeia Commission at the June 2020 session and published in Supplement 10.5. The details may also be consulted in the Knowledge database under ‘View history’.

UK medicines regulator gives approval for first UK COVID-19 vaccine

The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA). A copy of the press release is at the link: The BBC was reporting this morning that the UK is the first country worldwide to authorise a COVID-19 vaccine for a mass-vaccination programme.

Specific permits required to order Residual solvent solution class 1 CRS COVID-19 vaccine

As of the 1st January 2021, specific permits will be required to order R0250000 – Residual solvent solution class 1 CRS. This reference standard contains two controlled substances, carbon tetrachloride and 1,1,1–trichloroethane, which are ozone-depleting substances and, thus, prohibited in the EU except under certain conditions for laboratory and analytical uses. Users that require delivery within the EU, must provide a valid LabODS number to the EDQM when ordering the Ph. Eur. RS R0250000 reference standard, while any orders for delivery outside the EU are subject to licensing requirements.

Further information may be obtained from:

Updated Brexit post transition guidance

The MHRA has updated its guidance on the location and other authorised personnel requirements for the post transition period. Guidance on centrally authorised MAs, mutual recognition and decentralised MAs, existing UK national MAs, GB MAs, named distributor, manufacturing sites, quality control and QPs was updated. The MHRA has also published a new section on the definition of products placed on to the GB market. 

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