EMA, The European Drug Regualtor, Publishes Draft Reflection Paper on Ethical and GCP Aspects of Clinical Trial of Medical Products for Human use Conducted in Third Countries and Submitted in Marketing Authoirsation Application to the EMA.
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The European Medicines Agency (EMA) is a decentralised body of the European Union. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The EMA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure). The EMA provides the Member States and the institutions of the EU the best-possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use referred to it in accordance with the provisions of EU legislation relating to medicinal products. In addition article 58 of Regulation (EC) No. 726/2004 provides that the European Medicines Agency can give a scientific opinion, in the context of cooperation with the WHO, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the EU. Such opinions are drawn up by the Committee for Medicinal Products for Human Use (CHMP), following a review of the Quality, Safety and Efficacy data, analogous to the review undertaken via the centralised procedure, after consultation with the WHO. The standards applicable to both types of application (MAA or Article 58 Opinion) are the same and set out in Annex 1 to Directive 2001/83/EC.
In the context of this document the term “Third Countries” means countries that are not member states of the European Union/European Economic Area (EEA).
The revisions to the pharmaceutical legislation which came into place in 2004 increased emphasis on the ethical standards required of clinical trials conducted outside the European Economic Area (EEA) and included in Marketing Authorisation Applications (MAAs) submitted in the EEA for medicinal products for human use. The number of patients recruited in countries outside of the EEA is substantial (http://www.ema.europa.eu/Inspections/GCPgeneral.html). Some clinical trials are conducted across several regions, including Europe, whereas many others are conducted solely outside of the EEA.
Regulation (EC) No EC/726/2004 states in recital 16: “There is also a need to provide for the ethical requirements of Directive 2001/20/EC of 4 April 2001 of the European Parliament and of the Council 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 to apply to medicinal products authorised by the Community. In particular, with respect to clinical trials conducted outside the Community on medicinal products destined to be authorised within the Community, at the time of the evaluation of the application for authorisation, it should be verified that these trials were conducted in accordance with the principles of good clinical practice and the ethical requirements equivalent to the provisions of the said Directive.”
Paragraph §8 of the Preamble – Introduction and General Principles of Annex 1 to Directive 2001/83/EC states: “All clinical trials, conducted within the European Community, must comply with the requirements of Directive 2001/20/EC of the European Parliament and of the Council 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. To be taken into account during the assessment of an application, clinical trials, conducted outside the European Community, which relate to medicinal products intended to be used in the European Community, shall be designed, implemented and reported on what good clinical practice and ethical principles are concerned, on the basis of principles, which are equivalent to the provisions of Directive 2001/20/EC. Theyshall be carried out in accordance with the ethical principles that are reflected, for example, in the Declaration of Helsinki.”
Actions to meet this objective therefore need to encmpass EMA processes having an impact on clinical trials commencing prior to early phase clinical development. These processes include development of guidelines, Scientific Advice, Orphan Product Designation and Paediatric Investigation Plans and continue through to the finalisation of the CHMP opinion on the MAA, and post-authorisation activities.
In Dec 2008 the EMA published a strategy paper “Acceptance of clinical trials conducted in third countries for evaluation in Marketing Authorisation Applications” (http://www.ema.europa.eu/ Inspections/docs/22806708en.pdf) outlining four areas for action. These are:
1) Clarify the practical application of ethical standards for clinical trials, in the context of European Medicines Agency activities.
2.) Determine the practical steps undertaken during the provision of guidance and advice in the drug development phase.
3) Determine the practical steps to be undertaken during the Marketing Authorisation phase
4.) International cooperation in the regulation of clinical trials, their review and inspection and capacity building in this area.
In 2009 the EMA established a Working Group on third country clinical trials on medicinal products for human use. This working Group has been asked to develop practical proposals for tasks and procedures or guidance to address the four action areas set out above. The present document reflects the results of the discussion of this Working Group.
The best approach to achieving these objectives is to ensure that a robust framework exists for the oversight and conduct of clinical trials, no matter where in the world the clinical investigators’ sites are located and patients recruited. An international network of regulators from all countries involved, working together to share best practices, experiences and information and working to standards agreed and recognized by all, can provide an effective platform for such a robust framework. The EMA will seek to build and extend its relationship with regulators in all part of the world and with international organisations in order to work to achieve this.
The Reflection Paper highlights and emphasizes the need for cooperation between Regulatory Authorities involved in the supervision of clinical trials and the need to extend and link networks to support these activities.
The specific scope of this Reflection Paper extends to clinical trials conducted in third countries and submitted in marketing authorisation applications to the EMA in respect of medicinal products for human use.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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