PROPOSING NEW REGULATIONS ON CLINICAL DRUG TRIALS

The Ministry of Health is drafting a Circular amending and supplementing a number of articles of Circular 29/2018/TT-BYT dated October 29, 10 of the Minister of Health regulating clinical drug trials.

According to the provisions of Circular 29, regarding the legality of clinical drug trial records: The registration application and the content of the registration documents must be approved by the legal representative or legally authorized person of the organization. Register, sign and stamp according to regulations.

Documents issued by foreign management agencies must be consularly legalized according to the provisions of law on consular legalization, except for cases exempted according to the provisions of law.
In the draft, the Ministry of Health proposed that documents issued by foreign management agencies must be consularly legalized according to the provisions of the law on consular legalization, except for cases exempted according to regulations. provisions of the law.

In case the legal document is issued as an electronic copy, including cases where there is not enough signature, signer’s name and confirmation stamp of the competent State management agency of the country issuing the legal document, the agency The facility sends the results of self-searching legal documents from the English website of the agency issuing legal documents with the confirmation stamp of the organization or individual having the reagents or the facility, accompanied by a document providing information about Online search link to the Department of Science, Technology and Training.

Organizations and individuals with clinically tested drugs and testing facilities must be responsible before the law for the legality and accuracy of these documents and information and the self-search results of the organizations and individuals. people, basis.

Draft Circular amending and supplementing a number of articles of Circular 29 of the Minister of Health regulating clinical drug trials, clearly stating the amendments and supplements to Clause 1, Article 12, Appendix I, good drug testing practices Clinically as follows:

The clinical area of the facility that undertakes clinical drug testing (or according to the contract/document associated with the medical examination and treatment facility in case the facility undertakes vaccine/preventive drug testing to conduct research in the community). (non-clinical area) must meet technical standards…

Clinical drug testing is a scientific activity of researching drugs on volunteers to explore or determine the safety and effectiveness of the drug; recognize and detect harmful reactions due to the effects of drugs; drug absorption, distribution, metabolism, and excretion.

Source: Vietnam.vn

About STELLAPHARM

Stellapharm is one of leading generics pharmaceutical companies and strong producer of anti-viral drugs in Vietnam. The company established in Vietnam in 2000; and focuses on both prescription drugs and non-prescription especially in cardiovascular diseases, antiviral drugs, anti-diabetics drugs, etc. and our products are now used by millions of patients in more than 50 countries worldwide.

The company is globally recognized for its quality through our facilities have been audited and approved by stringent authority like EMA, PMDA, Taiwan GMP, local WHO and others.

Additional information for this article: Stellapharm J.V. Co., Ltd. – Branch 1
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