Regulatory news - March 2020

Keep up to date with regulatory news from around the world with the Cell and Gene Therapy Catapult regulatory newsletter.

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA Services and Inspections During COVID-19 Response

The MHRA announced that they are still contactable by email and telephone and there should be little to no impact on these services.

Enquiries relating to COVID-19 will be prioritised and therefore they may be some delay in response to general enquiries.

If you are due to meet with the MHRA, whether in person, video or teleconference, it is recommended organisations contact the meeting organiser.

The MHRA will only be conducting essential Good Practice (GxP) inspections during the outbreak. Other inspections will be deferred to a later date.

Please see here on how to contact the MHRA during this period, and here for further guidance on the conduct of GxP inspections.

 

Other

Spending for Research and Development will be Doubled by 2024 as New Budget Is Announced for the UK

Chancellor of the Exchequer, Rishi Sunak announced a budget on 11 March with a big increase for Research and Development (R&D). Public funding for R&D will increase by 15% in the next fiscal and will increase over the next three years to £22bn.

See here for more information.

 

EU

European Commission (EC)

Brexit and Rules for Medicinal Products

The EC and EMA have published a new notice to stakeholders to summarise the rules for medicinal products at the end of the transition period.

At the end of the transition period, medicinal products shipped from the UK to the EU will be “imported medicinal products” and the requirements for importers apply.

UK authorities will no longer undertake the role of supervisory authority. GMP compliance will be confirmed or reconfirmed by a new EU supervisory authority.

The Qualified Person of the EU manufacturing and importation authorisation holder will be responsible for certifying batches of medicinal product intended to be placed on the EU market have been manufactured in accordance with EU GMP requirements and the marketing authorisation.

Batches imported into the EU must undergo a full qualitative analysis of at least all active substances and other tests to ensure the quality of the medicinal product.

Active substances manufactured in the UK and imported into the EU must be accompanied by a written confirmation from the competent authority of the exporting third country confirming the standards of GMP are equivalent to those in the EU.

GMP certificates issued by a UK competent authority before the end of the transition period are to be considered as information on GMP compliance.

See here for the notice.

 

European Medicines Agency (EMA)

Impact of COVID-19 on Medicines Supply in the EU

The EMA has been closely monitoring the potential impact of COVID-19 on pharmaceutical supply chains in the EU. There have been no reports of current shortages or supply disruptions of medicines marketed in the EU due to the outbreak received at this point, however as COVID-19 develops, shortages and disruptions cannot be out ruled.

EU authorities including the EMA, European Commission and national competent authorities have organised a meeting to discuss potential impacts and develop strategies to ensure the continuity of supply of medicines.

See here for article.

EMA Recommends Granting Conditional Marketing Authorisation for Gene Therapy Zolgensma

The EMA has recommended granting a conditional marketing authorisation to the EU for Zolgensma. Zolgensma, AveXis, is a gene therapy to treat babies and young children with spinal muscular atrophy (SMA).

The EMA’s recommendation for conditional marketing authorisation is based on the preliminary results of a completed clinical trial and three supporting studies in patients with SMA, with different stages of disease severity.

The opinion will now be sent to the EC for the adoption of a decision on an EU-wide marketing authorisation.

See here for the press release.

 

Public Consultations

EUROPEAN COMMISSION (EC)

 

Title

Consultation

Period

Category

1

Targeted stakeholders' consultation on Annex 21: Importation of medicinal products, of the Eudralex volume 4

20 Mar

To

20 June 2020

Draft Guidance

2

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

20 Feb

To

20 May 2020

Draft Guidance

3

Public consultation on Europe's Beating Cancer Plan

04 Feb

To

28 Apr 2020

Public Consultation

 

FOOD AND DRUG ADMINISTRATION (FDA)

 

Title

Consultation

Period

Category

1

Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations

28 Jan 2020

To

29 April 2020

Draft Guidance

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