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This guideline is intended to summarise the available literature, the advice provided by existing national guidelines and the information from current national practice on the choice of comparator, and to outline some of the challenges arising when establishing what the comparator for a specific assessment should be.
This directive provides guidelines for ensuring the highest standards of quality and integrity in clinical research. In the European Union, a parallel guideline exists for clinical trials involving medical devices. This guideline is known as the international standard ISO 14155, and it serves as a harmonized standard within the European Union ...
The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and 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. [8]
Granted after an assessment of the documentation submitted by the applicant, a Certificate of Suitability (CEP) [18] provides proof that the methods used by a manufacturer or distributor result in an product whose quality complies with the requirements laid down in the corresponding Ph. Eur. monograph(s). The EDQM also runs an inspection ...
The Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012, the GPRD was rebranded as the Clinical Practice Research Datalink (CPRD). In April 2013, MHRA merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used for ...
The GRADE approach separates recommendations following from an evaluation of the evidence as strong or weak. A recommendation to use, or not use an option (e.g. an intervention), should be based on the trade-offs between desirable consequences of following a recommendation on the one hand, and undesirable consequences on the other.
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.