Written Confirmations for export of Active Substances manufactured in the UK Post Brexit

18th June 2019

The MHRA have published new guidance today to assist manufacturers in the event that the \'no-deal Brexit\'​ scenario happens in October.

MHRA GDP Pilot Scheme - OBERA: Office Based Evaluation and Risk Assessment programme

26th April 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) is trialling remote assessment of some distribution facilities which would impact holders of a Wholesale Dealer’s Licence (WDA(H)) whose main activities operate from a head office supplied from a number of ‘satellite’ facilities. For the companies selected, their satellite sites will be assessed remotely using information provided by the company in a standardised format.

Use eCTD for all regulatory activities in National Procedures (NP) by 1 January 2019

18th January 2019

MA applicants are reminded that following the revision of the European eSubmission roadmap, as of January 1, 2019, every file for the acquisition of a license to market a drug for human use must be submitted in eCTD format.

Revised guideline to assess risk of human medicines for the environment

4th December 2018

EMA has published a revision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation.

Submitting regulatory information on medical products if there’s no Brexit deal

25th September 2018

MHRA stakeholders are being informed of what they’ll need to do to continue to submit regulatory information to us in the unlikely event of a no-deal scenario.

Report from EMA - Industry survey on Brexit preparedness

13th July 2018

"This survey indicates that some companies need to step up efforts to ensure medicine supply in the EU.

Variations Required: Concomitant use of benzodiazepines / benzodiazepine like products and opioids

3rd May 2018

If you are the Marketing Authorisation Holder with existing MAs based on benzodiazepines/benzodiazepine like products and opioids, you may be required to submit additional variations in line with the recent CMDh advice.

MHRA's Guidance on GxP data integrity

28th March 2018

‘GXP’ Data Integrity Guidance and Definitions.

Brexit Update: Ireland and Denmark to drop fees for RMS transfer post-brexit

13th February 2018

In light of the pending withdrawal of the UK from the EU, the Irish and Danish regulators are willing to waive the fees for Regulatory procedure regarding Change of RMS.

An overview of the EU’s orphan designation programme - EMA Factsheet

2nd January 2018

The new factsheet published by European Medicines Agency in December last year explains what a rare disease is, how the EU programme works and what incentives are made available to developers.

EMA to relocate to Amsterdam, the Netherlands

20th November 2017

EMA to begin working immediately with Dutch government to ensure successful move by end of March 2019

EU-US mutual recognition of inspections of medicines manufacturers enters operational phase

1st November 2017

1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respec

Better labelling of excipients for safe use of medicines

16th October 2017

Updated annex to excipient guidelines has new safety advice for 15 excipients

MHRA's recently published guidance on human factors

19th September 2017

MHRA has produced guidance on the human factors aspects of design for medical devices including those in drug-device combination products.

EMA's Revised guideline on first-in-human clinical trials

9th August 2017

Guidance outlines strategies to identify and mitigate risks for trial participants

EMA's Pre-submission checklist for type II variation applications

11th July 2017

A new Guidance document is available for Marketing Authorisation Holders published by EMA to help improve the quality of variation and renewal applications.

EMA Regulatory Guidance for industry to prepare for the UK’s withdrawal from the EU

1st June 2017

The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies to prepare for the United Kingdom's withdrawal from the European Union. The guidance relates to both human and veterinary medicines.

EMA Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use

3rd May 2017

EMA and the European Commission have published a notice to marketing authorisation holders of centrally authorised medicines intended to remind them of their legal obligations in preparation for Brexit.

Changes to MHRA payment of fees

31st March 2017

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that paying for medicines licences, clinical trials and clinical investigations is changing from 1 April.

New MedRegs blog

9th February 2017

MHRA has launched an official blog providing expert insight into the latest regulatory thinking and all aspects of medicines regulation.

Standards for biological medicines - understanding them and how they make a difference

13th January 2017

The quality of biological medicines is assured by biological standards held by the British Pharmacopoeia (BP) and the National Institute for Biological Standards and Control (NIBSC)

Notification of intent to import an unlicensed medicinal product

7th December 2016

MHRA has published notification form to confirm that the import of an unlicensed medicinal product is requested by a doctor or dentist and is for use by his patients on his direct responsibility.

Export medical devices: special rules

8th November 2016

Outside the EU, manufacturers may need a Certificate of Free Sale (CFS) to export medical devices.

EU-US collaboration to boost medicine development for rare diseases

28th September 2016

New working group will share information and best practices--The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new ‘cluster’ on rare diseases to share experiences and best practices on each other’s

Pharmacovigilance Inspection Metrics Report April 2015 - March 2016

6th September 2016

MHRA Good Pharmacovigilance Practice Inspection Metrics for 2015/16 have been published.

MHRA - Updated Statement On The Outcome of The Brexit Referendum

21st July 2016

On 15th of July 2016, MHRA has updated their statement on Brexit Referendum

Introduction of a 'regulatory contact point' for marketing authorisation holders

17th June 2016

The European Medicines Agency implemented a 'regulatory contact point' within the EudraVigilance registration database. The EMA implemented this feature in the week commencing on 13 June 2016.

Single, central platform now mandatory for all PSURs

10th June 2016

PSUR repository facilitates information exchange on the safety of human medicines authorised in the EU

CMDh Update For New Applications

15th April 2016

Mock-ups, specimens and samples required for New applications

EMA update

19th January 2016

Human medicines: highlights of 2015

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