What is stringent regulatory authority?
A stringent regulatory authority (SRA) is a national drug regulation authority which is considered by the World Health Organization (WHO) to apply stringent standards for quality, safety, and efficacy in its process of regulatory review of drugs and vaccines for marketing authorization.
WHO as having stringent regulatory authorities?
The concept of a stringent regulatory authority or SRA was developed by the WHO Secretariat and the Global Fund to Fight AIDS, Tuberculosis and Malaria to guide medicine procurement decisions and is now widely recognized by the international regulatory and procurement community.
What is TRS in pharma?
WHO guidelines are known as WHO TRS (Technical Report Series)
Which are the regulatory authorities?
A regulatory authority is an autonomous enforcing body created by the government to oversee and enforce regulations regarding occupational health and safety. The role of the regulatory authority is to establish and strengthen safety standards and ensure consistent compliance with them.
What are the ICH regions?
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss …
What does the ICH do?
The ICH facilitates international electronic communication through the provision of Electronic Standards for the Transfer of Regulatory Information (ESTRI), giving the Electronic Common Technical Document (eCTD), allowing for the electronic submission of the Common Technical Document from applicant to regulator.
What are the ICH countries?
Regulatory Members
- ANVISA, Brazil.
- COFEPRIS, Mexico.
- HSA, Singapore.
- MFDS, Republic of Korea.
- MHRA, UK.
- NMPA, China.
- SFDA, Saudi Arabia.
- TFDA, Chinese Taipei.
What is an example of a regulatory authority?
Regulatory Authority means any national (e.g., the FDA), supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity involved in the granting of Regulatory Approval in any country in the Territory.
What is regulatory authority role?
Regulatory authorities will have the overall responsibility to promote , ensure and monitor compliance by approved ethics committees in a country with relevant legislation, regulations and guidelines including guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in the country.
What is ICH in regulatory?
This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.
What is the definition of ICH?
Medical Definition of ich : a severe dermatitis of freshwater fish caused by a protozoan of the genus Ichthyophthirius (I. multifiliis) and especially destructive in aquariums and hatcheries. — called also ichthyophthiriasis, ichthyophthirius.
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