Regulatory news - April 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 Regulatory Flexibilities Resulting from COVID-19

The MHRA have released guidance for industry on the flexible regulatory approaches being taken during the COVID-19 outbreak, with a view to supporting the healthcare products supply chain and wider response to the coronavirus outbreak in the UK.

The guidance details flexibility in regulatory approaches for areas including blood components for transfusion, clinical trials, inspections and good practice, medical devices, medicines regulation and pharmacovigilance. These regulatory flexibilities have been offered to provide flexibility in exceptional circumstances and are temporary.

For further information and to read the full MHRA Guidance, see here.

 

Approval of GxP documents when working from home during the Coronavirus (COVID-19) Outbreak

MHRA guidance has been published for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA as a result of the increase in remote working due to the COVID-19 pandemic.

The guidance covers the approval of paper documents when working from home and is intended to enable organisations to consider alternative methods for approving documents where wet ink signatures are no longer available.

For further information and to read the full MHRA Guidance, see here.

 

 

EU

European Commission (EC)

Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic (v3)

The EC guidance provides pragmatic and harmonised actions required to ensure the necessary flexibility and procedural simplifications needed to maintain the integrity of ongoing clinical trials, to ensure the rights, safety and wellbeing of trial participants and the safety of clinical trial staff during this global public health crisis.

An updated version of the guidance was released on 28th April. Updates have been made in relation to “distributor to trial participant IMP shipment”, “monitoring”, “remote source data verification” and “communication with authorities” since the release of version 2.

DG SANTE will host a webinar conference jointly with EMA and the Clinical Trials Coordination and Facilitation Group of Heads of Medicines Agency (HMA) to provide stakeholders with an overview of the most important elements of this guidance and additional clarification on 15th May 2020. Note: registration is required. 

The updated guidance is available here and further information on the webinar can be found here.

 

European Medicines Agency (EMA)

EMA Q&A on Regulatory Expectations for Drugs During Pandemic

The EMA, in collaboration with the European Commission and Heads of Medicines Agencies, have released a Q&A document to provide guidance on regulatory expectations for marketing authorisation holders and medicines during the COVID-19 pandemic.

The document discusses questions raised concerning marketing authorisations, manufacturing and imports, quality variations, product information and labelling.

A recent revision has also seen four additional questions added to the guidance relating to good manufacturing practice (GMP) and good distribution practice (GDP) certificates, Qualified Persons (QP) and adverse event reporting.

Further information on the guidance is available here, details of the recent updates can be found here. See here for the Q&A document.

 

EMA Annual Fee Adjustments

The EMA have released implementing rules and a corresponding explanatory note on the adjustments to fee levels, which come into effect this month. These documents include the new fees for all types of procedures handled by the Agency, except for pharmacovigilance procedures.

 

Note: new fees have been introduced for consultations on medical devices (human medicines).

 

Full details of the new fee levels are available in Commission Regulation (EU) No 2020/422 amending Council Regulation (EC) No 297/95.

 

 

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

07 May 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

28 July 2020

Draft Guidance

 

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