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Focus on Regulation

Category Archives: Pharmaceutical & Biotechnology

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To certify or not to certify? FDA has answered the question

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674 certifications stating that they have complied with their obligations to submit required clinical trial information to clinicaltrials.gov.  

EMA publishes a Draft Guideline on Trial Master Files to facilitate the conduct and management of clinical trials

In April 2017, the European Medicines Agency (EMA) issued a draft guideline (“Draft Guideline“) concerning the Trial Master Files (“TMF”) for public consultation. The Draft Guideline updates the previous guideline on TMF that was issued in 2013 in the form of a reflection paper. The Draft Guideline incorporates further guidance concerning international guideline for good

Personalised Medicines at the top of the European Agenda

In March 2017, the European Medicines Agency organised a workshop concerning personalised medicine. The results of the workshop have just been published. The workshop discussed the views of patients, healthcare professionals and payers regarding personalised medicine. During the workshop future challenges and related actions, that should be taken regarding personalised medicine, were identified. The challenges

UK Government Given Additional Powers to Control NHS Medicine Prices

The new Health Service Medical Supplies (Costs) Act 2017 came into force on 27 April 2017, giving the Department of Health greater powers to control the cost of medicines supplied to the National Health Service (NHS). The cost of branded medicines supplied to the NHS is regulated through two mechanisms – the Pharmaceutical Price Regulation

EMA seeks to support the use of patient registries and to improve dialogue between various stakeholders

  In September 2015, the European Medicines Agency (EMA) launched the initiative for patient registries. The purpose of the initiative is to improve the benefit-risk evaluation of medicinal products for human use. The EMA’s initiative for patient registries focuses mainly on the ways in which existing patient registries could be improved. This could be systematically considered

European Commission publishes recommendations concerning the summary of product characteristics and patient information leaflet for medicinal products

  The European Commission (EC) has published a report (Report) recommending improvements in the summary of product characteristics (SmPC) and the Patient Information Leaflet (PIL) of medicinal products for human use. The report identifies shortcomings concerning the SmPC and the PIL, and provides recommendations on the way in which SmPC and PIL could be improved.

French Sunshine Regulations: The Puzzle Now Completed and in Force

The French sunshine regulations require industry to report certain agreements along with the fees and other benefits provided to various stakeholders in the healthcare sector. Sunshine regulations were amended in January 2016 to increase transparency. Some specifics of these changes were partly established by an implementing decree dated 28 December 2016. Through the publication of

The MHRA issues new guidance concerning common issues in clinical trial applications

On 22nd March 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance (“Guidance“) identifying the most common issues that the Agency has encountered during the validation and review of Clinical Trial Authorisation (CTA) applications. The Guidance is intended to assist clinical trial sponsors in identifying avoidable delays, to the benefit of

The EU Court of Justice dismisses EMA’s appeals in interim measures and suspends the release of clinical study report to third parties

On March, 1st 2017, by Order of its Vice-President, the Court of Justice of the EU (“CJEU”) upheld the suspension of the release to third parties of a clinical study report concerning the medicinal product Translarna granted by the General Court in July 2016. On the same day, by Order of its Vice-President, the CJEU

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to Continue Shifting Inspections and Enforcement Focus to Asia

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug Administration (FDA) and the European Union (EU) today announced that they have enhanced their agreement on mutual recognition

Extension to the EMA’s Multinational Assessment Team Initiative as of April 2017

Starting in April 2017, the European Medicines Agency (“EMA”) will expand the Multinational Assessment Team (“MNAT”) Initiative to post-authorisation assessments. From this date, the MNAT Initiative will allow national competent authorities not only to participate actively in the development of new medicinal products, but also to be involved in the extensions of marketing authorisations for

New Belgian Sunshine Requirements applicable to all pharmaceutical and medical devices from 1 January 2017

On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act “) was adopted by the Belgian Ministry for Public Health[1].  The Sunshine Act introduces several substantial changes to the current Belgian legal and regulatory framework for medicinal products and medical devices. Background The Sunshine Act imposes a

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

On January 18, 2017, as one of the last actions of the outgoing Obama administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the “Agencies”) issued a final rule overhauling the regulations (82 Fed. Reg. 7149, Jan. 19, 2017) intended to safeguard individuals participating in research, often referred to

UK to Seek Close Relationship with EMA Post-Brexit

UK Secretary of State for Health, Jeremy Hunt, has stated in a Health Select Committee meeting that he does not expect the UK to remain part of the European Medicines Agency (“EMA”) or the EU medicines regulatory framework post-Brexit, but that the UK should seek a very close working relationship with the EMA and the

Just in Time: FDA Finalizes Guidance on Assessment of Abuse Potential of Drugs

On January 17, 2017, just in time to evade the President’s Regulatory Freeze Memorandum, FDA announced the availability of a final guidance entitled “Assessment of Abuse Potential of Drugs.”  The guidance is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their drug product has

What’s ahead with the new Trump administration?

It’s no secret that the life sciences industry has had some challenging moments with lawmakers in recent years. And despite efforts by the White House, Congress, FDA, and other regulatory agencies, in most cases the law continues to lag behind the industry’s pace of innovation. So, how will the Trump Administration address the industry’s challenges?