European Union medicines regulation

European Parhament and Council of the European Union (2014) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Off J Eur Union L(158) l-76. http //eur4ex.europa.euAegal-content/ EN/TXT/PDF/ uri=OJ JOL 2014 158 R 0001 from=EN. Accessed 14 July 2014... 

The CTD format has been incorporated into the E U regulations and is set out in the revised version of Annex I to directive 2001/82/EC, which was published as Commission Directive 2003/63/EC. It is also supported by detailed guidance in the Rules Governing Medicinal Products in the European Union, Volume 2B - Presentation and content of the dossier - CTD2001 edition. The relationship between the CTD format and the previous four-section format that was used in the E U is shown in Table 6.1. 

The Community procedure for establishing MRLs of veterinary medicines in foodstuffs of animal origin is set down in Council Regulation (EEC) No. 2377/90 as amended by Council Regulation (EC) No. 1308/1999. The regulations are supported by detailed guidance contained in The Rules Governing Medicinal Products in the European Union, Volume 8 - Maximum Residue Limits. 

Attempts to harmonize European pharmaceutical laws were accelerated in the 1980s. From 1985 onwards, a substantial number of European pharmaceutical directives have been adopted. This entire legislation has been published in the form of a nine-volume series entitled The Rules Governing Medicinal Products in the European Union (Table 4.11). These volumes form the basis of EU-wide regulation of virtually every aspect of pharmaceutical activity. 

The raft of rules, regulations, guidelines and procedures (both the European Union and ICH) governing the human medicinal products in the European Union can be found in the following five volumes published by the European Commission ... 

Regulation of human medicinal products in the European Union... 

Once a medicinal product is authorised in the European Union, even if it is not marketed, the MAH is required to submit a PSUR. These PSURs were previously required to be prepared at 6-monthly intervals for the first 2 years following the medicinal product s authorisation in the European Union, annually for 2 years, at the first renewal, and then 5-yearly at renewal thereafter. However, as shown later. Regulation 726/2004 has increased the frequency of PSURs. 

In the European Union, the medicinal products incorporated into feeding stuffs for prophylactic, coccidiostatic, and growth-promotion purposes are not subject to the above-mentioned authorization procedures for establishing MRLs. Being regulated under Directive 70/524/EEC (45) and its major amendments, especially 84/587/EEC (46) and 96/51/EEC (47), these products do follow, however, a centralized procedure through an EU system. Although no formal MRLs have been yet established for these products, the types of toxicity and residues data mentioned above are also required (48). 

The release of a new drug onto the market must be approved by the regulating authority for that country. For example, in Britain this is the Medicines Control Agency (MCA), in the European Union it is the European Medicines Evaluation Agency (EMEA) and in the USA the US Food and Drugs Administration (FDA). These bodies, which are essentially consumer protection agencies, issue a so called product licence or marketing authority (MA) when they are satisfied... 

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. 

Within the European Union, the European Commission (EC) has codified the GLP requirements for medicinal products in the Introduction and General Principles chapter of Directive 2003/63/EC [31]. Within this document it is stated that nonclinical (pharmacotoxicological) studies must be carried out in conformity with the provisions related to GLP laid down in Council Directives 87/18/EEC3 on the harmonization of regulations and administrative provisions relating to the application of the principles of GLP and the verification of their application for tests in chemical substances and 88/320/EEC4 (corrigenda 1, 2, and 3) on the inspection and verification of GLP [32,33], The OECD principles have been adopted by the European Union and published, in their revised form, in the appendix to Directive 2004/10/EC [32], The GLP Web site of the EC contains detailed reference information and links for member state GLP compliance [34],... 

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