National Drug Policy and Authority (Conduct of Clinical Trials) Regulations, 2014 (S.I. No. 32 of 2014).

These Regulations, made by the Minister responsible for health under section 64 of the National Drug Policy and Authority Act, and on the advice of the National Drug Authority, provide with respect to clinical trails for the testing of drugs. Authorisation for clinical trial shall be granted by the National Drug Policy and Authority for drugs registered under the Act and for drugs that are not registered under the Act. The principal investigator shall hold a university degree in medicine, pharmacy, pharmacology, toxicology, biochemistry, veterinary medicine or any other related profession. The Regulations also concern the use of animals in clinical trails.