Which is the correct national regulatory authority?
Which is the correct national regulatory authority?
The Central Drugs Standard Control Organisation(CDSCO)under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India.
What are the key responsibilities of the drug regulatory authorities?
Their main duties include issuing licensing to companies to allow manufacturing, monitoring these activities and responding to any issues that might arise. In addition, they also produce quality and safety information as guidance for use of health related products.
Which body regulates hospitals in India?
As per existing law the health sector has provision for regulation under three different authorities. The Medical council: The Medical Council of India and the respective state Councils have to regulate medical education and professional practice.
Is the FDA a regulatory authority?
The scope of FDA’s regulatory authority is very broad. FDA’s responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact.
What do regulatory professionals do?
Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials. They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
What is the current role of National Drug Authority in traditional medicine development and regulation?
The Act established a National Drug Policy and National Drug Authority to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda as a means of providing satisfactory healthcare and safeguarding the appropriate use of drugs.
What are ICH countries?
Regulatory Members
- ANVISA, Brazil.
- HSA, Singapore.
- MFDS, Republic of Korea.
- NMPA, China.
- SFDA, Saudi Arabia.
- TFDA, Chinese Taipei.
- TITCK, Turkey.
What is regulatory authority in clinical research?
Regulatory authorities are responsible to review clinical trials of both non- registered medicinal substances and new indications of registered medicinal substances. Regulatory authorities has the responsibility to close down an on going trial in the case there are serious breaches of Good Clinical Practice.