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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.
A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice for international consistency of quality research.
However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 [5] The ICH and the FDA released draft specifications and guides in April 2016, and on May 13 there was an ICH "teleconference" to discuss the guidance and any queries or clarifications that might be necessary. [6]
The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). [ 1 ] [ 2 ] After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada [ 3 ] and Switzerland.
Health and Youth Care Inspectorate Inspectie Gezondheidszorg en Jeugd (IGJ) 1995 New Zealand: Medicines and Medical Devices Safety Authority (Medsafe) 2013 Norway: Norwegian Medicines Agency (NOMA) 1995 Poland: Chief Pharmaceutical Inspectorate (CPI) 2006 Portugal: National Authority of Medicines and Health Products, IP
Evidence-based dentistry (EBD) is the dental part of the more general movement toward evidence-based medicine and other evidence-based practices. The pervasive access to information on the internet includes different aspects of dentistry for both the dentists and patients.
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
The General Dental Council (GDC) is an organisation which regulates dental professionals in the United Kingdom. It keeps an up-to-date register of all qualified dentists and other dental care professionals such as: dental hygienists , dental therapists , dental nurses , dental technicians and clinical dental technicians. [ 1 ]