On 12/9/2018, the Ministry of Health issued Circular No. 21/2018 / TT-BYT regulating registration of traditional medicines. This Circular takes effect on October 28, 2018.
Circular No. 21/2018/TT-BYT details the following: Criteria for determining traditional medicines are be exempted from clinical trials, Phase 4 clinical trial, full clinical trials in Vietnam and clinical data requirements are required to ensure safety, efficiently serving as a basis for granting certificates of circulation of traditional medicines. Dossiers and procedures for granting, extending, changing, supplementing and withdrawing registration papers for circulation of traditional medicines and materia medica.
Circular applies to subjects: traditional medicine; traditional medicine made in traditional or modern form; The list of materia medica must be registered for circulation by the Ministry of Health in accordance with Article 93 of Decree No. 54/2017/ND-CP detailing a number of articles and measures to implement the Law on Pharmacy.
Accordingly, traditional medicines that apply for circulation registration certificates must continue to monitor safely and effectively if they fall into one of the following cases:
– Traditional medicines containing poisonous herbs on the list of materia medica of toxic origin in Appendix III issued together with Circular No. 42/2017/TT-BYT;
– The toxic drugs are not marked * on the list of botanical and botanical toxicological substances in Annexes I and II issued together with Circular 42/2017/TT-BYT;
– Traditional medicines do not have adequate clinical data to ensure safety and effectiveness;
– Traditional medicines are exempt from some clinical trials.
In addition, traditional medicines for extension of circulation registration certificates are also subject to continued monitoring when there is insufficient clinical data on safety assurance and effectiveness. Note that the deadline for issuance and renewal of circulation registration certificates for traditional medicines is 03 years.
It can be seen that the Circular No. 21/2018/TT-BYT was promulgated to create a clear legal framework for registration of traditional medicines, preserving traditional remedies and at the same time ensuring the role of state management.