Last week’s round -up;
08-12 February 2021

published 15 Feb 2021

UK MHRA is part of the Access Consortium along with the Australia Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic

The consortium is a medium-sized coalition of regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements. The original consortium, formed in 2007 and known as ‘ACSS’, comprised the national regulatory authorities of Australia, Canada, Singapore and Switzerland. In October 2020, the MHRA joined, and the group’s name was changed to ‘Access’. The consortium’s goal is to maximise international co-operation between partners in the consortium, reduce duplication, and increase each agency’s capacity to ensure patients have timely access to high quality, safe and effective therapeutic products. The Access consortium has developed 2 authorisation procedures: the New Active Substance Work Sharing Initiative and the Generic Medicines Work Sharing Initiative. The MHRA commenced work-sharing applications with Access partners from 1 January 2021. MHRA has just added the Expression of Interest (EOI) form for the New Active Substance Work Sharing Initiative to the MHRA website.

This EOI form and further details on the Access consortium are available at the following link:

UK MHRA updates Guidelines on UK Orphan Medicinal Products registration

Products with an orphan designation (OD) in the EU can be considered fora Great Britain (GB) orphan MA.  A UK-wide orphan MA can only be considered in the absence of an active EU OD.  There is no pre-authorisation OD in GB.  The MHRA has published a list of authorised orphan medicinal products registered by the UK at the following link: Orphan registered medicinal productsFor GB (England, Scotland and Wales), the MHRA offers incentives in the form of market exclusivity and full or partial refunds for MA fees to encourage the development of medicines in rare diseases. Waiver from Scientific Advice fees will also be available for UK-based SMEs.  On grant of a MA with orphan status, the product will benefit from up to 10 years of market exclusivity from similar products in the approved orphan indication.  The start of this market exclusivity period will be date of first approval of the product in GB.  Market exclusivity periods for Centrally authorised orphan medicine MAs that are converted to UK MAs will continue to apply.  Orphan medicines authorised in GB with the results of studies from a paediatric investigation plan (PIP) included in the product information are eligible for an additional 2 years of market exclusivity.

Further details are available at the following link:

EMA product-specific bioequivalence guidance

The EMA has released the following product-specific bioequivalence guidance:

· Draft guidance for Deferasirox Dispersible Tablets, Film-coated Tablets and Granules, which is open for consultation until 31st March 2021.

· New guidance for Levothyroxine Tablets, effective from 1st July 2021.

· Revised guidance for Sorafenib 200 mg Film-coated Tablets.

Nitrosamines Updates

A new study has reported elevated levels of the potentially carcinogenic nitrosamine NDMA after the ingestion of ranitidine capsules across a range of physiologic conditions, with levels that greatly exceed FDA guidelines under some conditions. These results support the Agency’s request for all ranitidine products to be withdrawn from the market in April 2020. The EMA has released the following updates related to nitrosamine impurities: updated response templates, updated questions and answers guidance document and a new requirement to test medicinal products containing rifampicin for nitrosamines before releasing them to the market.

Further details on the ranitidine study and the EMA nitrosamine updates may be found at the following link:


Search Real Regulatory