Efficacy of medicinal products

The Rules Governing Medicinal Products in the European Communities. Vol. III. Guidelines on the Quality, Safety and Efficacy of Medicinal Products for Human Use. Brussels Office for Official Pubhca-tions of the European Communities, 1989. 

Advising on the safety, quality or efficacy of medicinal products (e.g. advising the Agency on those licensing applications that are currently considered by the CSM) ... 

Applicants are free to solicit advice from individual Member States and according to various surveys conducted by the European Federation of Pharmaceutical Industries and Associations, they often do. Apart from the FDA, these surveys reveal, the EU Member States most often consulted are Germany, France, Sweden and the United Kingdom. Flowever, it is often important to secure a pan-European advice. Article 51 of Council Regulation EEC/2309/93 requires the EMEA to provide the Member States and the institutions of the Commimity with the best possible scientific advice on any question relating to the evaluation of the quality, the safety and the efficacy of medicinal products for human... 

Volume III Guidelines on the quality, safety and efficacy of medicinal products for human use (1989)... 

To give advice with respect to safety, quality and efficacy of medicinal products ... 

The revised legislation (Regulation 726/2004) established a new committee within the structure of the EMEA named the Committee on Herbal Medicinal Products (HCMP). This committee has the task to provide the MS and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products , as well as advising interested parties on the conduct of the various tests and trials necessary to demonstrate quality, safety and efficacy. 

Quality control should especially pay attention to the compliance with specifications which bear on the efficacy of medicinal products, namely ... 

Committee for Proprietary Medicinal Products (1995) Biostatistical methodology in clinical trials in applications for marketing authorizations for medicinal products. CPMP Working Party on Efficacy of Medicinal Products Note for Guidance ttt/3630/92-EN. Statistics in Medicine 14 ... 

EC-Note for Guidance Investigation of Chiral Active Substances, CPMP Working Party on Quality of Medicinal Products. CPMP Working Party on Safety of Medicinal Products. CPMP Working Party on Efficacy of Medicinal Products. 1993 Oct, III/3501/91EN. 

In 1990, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) initiated a process involving both regulators and industry as partners in scientific and technical discussions on harmonization of testing procedures required to ensure and assess the safety, quality, and efficacy of medicinal products containing new drugs. 

Guidelines on the quality, safety and efficacy of medicinal products for human use have also been formulated in Europe [18]. Witte etal. [12] reviewed the guidelines on chirality in the European Community. In general, the European guidelines are similar to those of the FDA, as both are based on the same body of scientific knowledge [13]. These guidelines have been published by the Committee for Proprietary Medicinal Products (CPMP), in two volumes (II and III) of the mles governing medicinal... 

Committee for Proprietary Medicinal Products Working Parties on Quality, Safety, and Efficacy of Medicinal Products. Note for guidance investigation of chiral active nF3501/91, 1993. 

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