The Ministry of Health is drafting a Circular amending and supplementing a number of articles of Circular 29/2018/TT-BYT dated October 29, 2018 of the Minister of Health regulating clinical drug trials.
According to Circular 29, regarding the legality of clinical trial dossiers: The registration application and the contents of the registration dossiers must be signed and sealed by the legal representative or legally authorized person of the registering organization according to regulations.
Documents issued by foreign management agencies must be consularly legalized in accordance with the provisions of law on consular legalization, except in cases of exemption under 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 in cases of exemption according to the provisions of the law.
In case the legal documents issued are electronic copies, including cases where there are not enough signatures, names of signers and confirmation stamps of the competent State management agencies of the country issuing the legal documents, the facility shall send the results of self-searching the legal documents from the English website of the agency issuing the legal documents with the confirmation stamp of the organization or individual with the test drug or of the facility, along with a document providing information about the online search link to the Department of Science, Technology and Training.
The Ministry of Health is drafting a Circular amending and supplementing a number of articles of Circular 29 regulating clinical drug trials.
Organizations and individuals with drugs for clinical trials and facilities accepting trials must be responsible before the law for the legality and accuracy of these documents and information and the results of self-research by the organization, individual, or facility.
The Draft Circular amending and supplementing a number of articles of Circular 29 of the Minister of Health regulating clinical drug trials clearly states the amendment and supplement to Clause 1, Article 12, Appendix I on good clinical trial practices as follows:
The clinical area of the facility undertaking clinical drug trials (or according to the contract/document associated with the medical examination and treatment facility in case the facility undertaking vaccine/preventive drug trials conducts research in the community without a clinical area) must meet the technical standards...
Clinical drug trials are scientific activities that research drugs on human volunteers to explore or determine the safety and effectiveness of drugs; identify and detect adverse reactions caused by drug effects; and the ability to absorb, distribute, metabolize, and excrete drugs .
Source
Comment (0)