TMQA Latest News

MHRA website moves to www.gov.uk

As of 28 January 2015, the MHRA website can be found on the gov.uk website. The official MHRA web address is: www.gov.uk/mhra. As part of the move, the content of MHRA has been rewritten so it is easier and clearer to understand. Bookmarks and saved links to the old MHRA website will still take you to the information you need. You’ll automatically be redirected to the relevant content on www.gov.uk.


MHRA helps Eisai develop its first European site

The MHRA has helped the Japanese pharmaceutical company, Eisai, to develop its first European research and production site. This is the third case study by the Innovation Office at the MHRA.  The Innovation Office was established in 2013 to help support the UK Prime Minister’s Life Sciences strategy and was developed as a place that those developing medicines and devices could turn to if they didn’t know who to contact at the MHRA for advice.

In the case of Eisai, by involving the MHRA inspectorate early in the design stage of their research and production site, it ensured that the development met the regulatory requirements for the type of site, which included a number of innovative concepts and design philosophies.  The MHRA helped by: attending advisory meetings to facilitate quick decision making; reviewing the conceptual approach to make sure it was on the right track; providing invaluable feedback at an early stage; helping Eisai to mitigate risk and avoid expensive changes to design later on in the process; working to support Eisai in ensuring compliance.

Source:  https://www.gov.uk/government/news/mhra-helps-japanese-pharmaceutical-company-to-develop-its-first-european-site


FDA issues guidance agenda on new and draft guidances it plans to publish in 2015

Earlier this month the FDA’s Center for Drug Evaluation and Research (CDER) published a list of new and revised guidances that it plans to publish during 2015. Those relating to clinical trials include, but are not limited to:

  • Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
  • Multiple Endpoints in Clinical Trials
  • Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators
  • Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers

The full list can be found on the FDA website: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417290.pdf


EMA recommends suspending medicines over flawed studies

The EMA has recommended that a number of medicines, whose authorisation in the EU was primarily based on clinical studies conducted by the Indian CRO, GVK Biosciences, should be suspended.  The recommendation is the result of a review carried out by the EMA of over 1000 pharmaceutical forms and strengths of medicines studied at the GVK Biosciences’ facility in Hyderabad, India.

Concerns over this facility were raised following an inspection by the French Regulatory Authority which revealed data manipulation of ECGs during the conduct of some studies of generic medicines. For over 300 of the pharmaceutical forms and strengths studied at GVK, sufficient supporting data from other sources were available, hence these will remain on the market in the EU as the EMA is satisfied with the available data.  For those medicines that lack the data from other studies, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended suspension unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs. The decision on whether a medicine is critical for patients lies with the national authorities of EU Member States depending on the situation in their country. For medicines that are considered critical, companies are given 12 months to submit additional data.

The full list of medicines for which the CHMP recommends suspension is available on the EMA website.

Source:  http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/01/news_detail_002256.jsp&mid=WC0b01ac058004d5c1


EMA launches electronic platform for Safety Reports

 

On 26 Jan 2015, the EMA launched a central electronic repository to facilitate assessment of medicines safety reports.  This repository has been created in accordance with the pharmacovigilance legislation of the EU and will contain all information related to Periodic Safety Update Reports (PSUR) in the EU and will allow assessment of PSURs by medicines regulatory authorities in the EU.

Pharmaceutical companies are required to submit PSURs to the EMA on a periodic basis.  The PSUR summarises the results of an evaluation by the pharmaceutical company of the benefits and risks of the authorised medicine.  The EMA then uses this information to determine if new risks are identified or if the risk-benefit balance of a medicine has changed and to take appropriate action.  The central repository stores PSURs, PSUR assessment reports, comments, and final outcomes, and gives secure access to authorised users from national competent authorities in EU Member States, the EMA, Agency committees, and the European Commission. It ensures that all those involved in benefit-risk assessments of medicines have timely access to all relevant documents in one location.

Webinars on the PSUR repository for the pharmaceutical industry will be organised in Feb 2015 followed by weekly question and answer sessions.

Source: 

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/01/news_detail_002257.jsp&mid=WC0b01ac058004d5c1