1. Introduction Shortly after updating the related draft Questions and Answers document (see our blog), the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed consent and patient recruitment procedure template. The second document is an updated clinical trial Application Form.
Tag Archives: Clinical Trials Regulation
European Commission provides clarification regarding the implementation of the Clinical Trials Regulation
1. Introduction The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing clinical trials within the Regulation. The draft document has been submitted for discussion to the Expert Group on Clinical Trials.
UK Government Publishes Guidance for Life Sciences Companies on Brexit Transition
The UK Government has published guidance for life sciences companies on the Brexit implementation period, which is intended to take effect from 30 March 2019 to the end of 2020. If the draft Withdrawal Agreement is finalised by the UK and EU, during the implementation period the UK will no longer be an EU Member
UK committed to implementing EU Clinical Trials Regulation post-Brexit
The UK Government has confirmed that it is committed to implementing the new EU Clinical Trials Regulation (EU) 534/2014 (“EU CTR”) into UK law post-Brexit. The EU CTR entered into force in 2014 but will not apply until 6 months after the European Commission issues a notice confirming that the new EU clinical trials portal
UK Parliamentary Committee Publishes Life Sciences Brexit Negotiation Recommendations
The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. The Committee’s report sets out recommendations for the UK Government in its negotiations with the EU on the terms of the UK’s
European Commission released GMP Guidelines for Investigational Medicinal Products
On 8 December 2017, detailed EU guidelines on good manufacturing practices (“GMP”) for investigational medicinal products for human use were adopted by the European Commission under the EU Clinical Trials Regulation. The document supplements the EU Delegated Regulation adopted in 2017 setting out GMP obligations for investigational medicinal products. The Delegated Regulation establishes a pharmaceutical
FDA and OHRP Finalize Joint Guidance on IRB Meeting Minutes
The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS), issued final joint guidance on maintaining meeting minutes for Institutional Review Boards (IRBs).
Adoption of the French Government Order Relating to Study Involving Human Persons Pursuant to the Public Health Law Dated 26 January 2016
Regulation No. 536/2014 repealed Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The main purpose of the Regulation is to harmonize and simplify
European Commission Launches Public Consultation on New Implementing Act on GMP
On 28 August 2015, the European Commission launched a public consultation on a new Implementing Act on principles and guidelines on good manufacturing practice (“GMP”) for medicinal products for human use. Article 46(f) of the Community Code relating to medicinal products for human use imposes on the holder of a marketing authorisation the obligation to comply