European Union clinical trial applications

Similar to the US requirements, there are two regulatory steps to go through before a drug is approved to be marketed in the European Union. These two steps are clinical trial application and marketing authorization application. There are 27 member states in the European Union (as of August 2007) clinical trial applications are approved at the member state level, whereas marketing authorization applications are approved at both the member state or centralized levels. 

Clinical investigations are clearly the most critical and demanding stage in the new dmg development phase. When a dmg company believes it has sufficient preclinical testing data to show that a new dmg candidate is adequately safe for initial small-scale clinical studies, the company assembles and submits an investigational new dmg (IND) application in the United States or a clinical trial application (CTA) in the European Union. The IND or CTA is the prerequisite for a company to obtain... 

Compliance with the requirements of Directive 2001/20/EC is important. This is because Annex I to Directive 2001/83/EC (as amended) expressly requires that for the purpose of obtaining a marketing authorization, all clinical trials conducted within the European Union to comply with Directive 2001/20/EC. For clinical trials conducted outside the European Union and the data of which are used in support of an application for a marketing authorization, such clinical trials must be designed, implemented, and reported on the basis of principles that are equivalent to the provisions of Directive 2001/20/ EC and carried out in accordance with the ethical principles that are reflected in the Declaration of Helsinki. 

Clinical trials are regulated by individual member states in the European Union. An applicant (or sponsor) submits data on the investigational medicinal product (IMP), and details of the proposed clinical trial, to the competent authority in the country in which the trial is to be carried out. The ethics committee responsible for the site where the trial is to take place also needs to give approval. 

Compassionate use is a treatment option that allows the use of an unlicensed medicine. Compassionate use programmes are for patients in the European Union (EU) who have a disease with no satisfactory authorised therapies or cannot enter a clinical trial. They are intended to facilitate the availability to patients of new treatment options under development. To qualify for a compassionate use programme, the manufacturer calls on the national authorities for permission. The manufacturer must submit a request for the granting of a marketing authorisation or he must perform research in the context of a research programme with a cohort. Compassionate use procedures are also applicable for unlicensed medicines withdrawn from the market or for off-label use of licensed medicines. 

Boris was greatly respected and liked by his colleagues, students, and collaborators. His ability to make trusted friends led to a considerable amount of national and international collaboration. The latter included Nippon Chemicals, Union Carbide, and major projects, such as the European-Commission-funded INTAS project involving teams of chemists from the United Kingdom and across Russia. He was also a key contributor to a substantial pharmaceutical project with university and hospital scientists in the United Kingdom that, with commercial support, led to clinical trials and potential medical applications. 

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