Regulatory News - June 2021

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)

UK-Canada Trade Continuity Agreement

Since the Comprehensive Economic and Trade Agreement ceased to apply in the UK from 1st January 2021, Canada and the UK agreed on an interim agreement until a free trade agreement was in place. The comprehensive UK-Canada Trade Continuity Agreement (TCA) has now entered into force (as of 1st April 2021).

This agreement means that Canada and the UK will continue to recognise Certificates of GMP Compliance issued by each country’s regulatory agencies and will accept batch testing certificates held by a manufacturer without re-control of that batch at import.

See here for further information and the full UK-Canada TCA.

 

EU

European Medicines Agency (EMA)

CHMP Recommends First CAR-T Cell Therapy for Multiple Myeloma

The EMA has recommended granting a conditional marketing authorisation for Europe’s first chimeric antigen receptor T-cell therapy for multiple myeloma.

Abecma (idecabtagene viceucel) is a gene therapy developed by Celgene Europe BV and is currently pending EC decision for the treatment of adult patients with relapsed and refractory multiple myeloma. The CHMP’s positive opinion is based on assessment by the EMA’s Committee for Advanced Therapies.

For further information, see here.

EMA Consultation on ICH S12 Guideline on Nonclinical Biodistribution Considerations for Gene Therapies

The EMA has released a public consultation on the ICH S12 guideline on nonclinical biodistribution considerations for gene therapies, the consultation period running from 24th June 2021 to 24th October 2021. The guideline recently reached Step 2b of the ICH process after being endorsed at the ICH Assembly virtual meeting.

The guideline covers design of nonclinical biodistribution studies including test article, the animal or species to study, size of the group and sex of animals to be assessed, the route of administration, dose level selection and time points for sample collection. Assay methods for quantification of the amount of genetic material in the products tissue and biofluids, immunogenicity and triggers for additional nonclinical biodistribution studies are also covered

For further information, see here. The public consultation is available here.

 

INTERNATIONAL

International Council for Harmonisation (ICH)

ICH Agree New Areas for Harmonisation

The ICH released an update on the continued growth and advancement of the ICH, following a virtual meeting of the ICH Assembly.

During the meeting, three topics were identified as new areas for harmonisation including stability testing in relation to biotechnological and biological products. Revisions are planned for ICH Q1 Guidelines on Stability Testing and ICH Q5 Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products.

To read the full announcement from the ICH Assembly Meeting, see here.

Pharmaceutical Inspection Co-operation Scheme (PIC/S)

PIC/S Adapting EU GMP Annex 16 on Authorised Person and Batch Release

The PIC/S has announced plans to transpose the EU GMP Annex 16 on batch release by a qualified person (QP) in order to harmonise international requirements regarding product release. Annex 16 came into effect on 15th April 2016 and covers certification of a QP that can perform batch release on products for marketing authorisation holders in the EU or labelled for export. The QP certifies that a drug has been manufactured in accordance with the marketing authorisation and complies to GMP.

Following several rounds of internal consultation, the PIC/S Committee have agreed to progress to Step 2 of the consultation process, enabling PIC/S Participating Authorities to consult with stakeholders. The stakeholder consultation, launched on 15th June 2021 for a period of 3 months, focusses on national stakeholders of non-EU/EEA Members of PIC/S, considering that the EU/EEA Members already apply EU Annex 16.

For further information, see here

 

Public Consultations

EUROPEAN MEDICINES AGENCY (EMA)

 

Title

Consultation

Period

Category

1

Draft toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications

02 Feb 2021

To

31 Jul 2021

Public Consultation

2

ICH S12 guideline on nonclinical biodistribution considerations for gene therapies

24 Jun 2021

To

24 Oct 2021

Public Consultation

 

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