Jane Tsai and Eddie Shih
I. Summary of the Draft Amendments
Taiwan’s Central Competent Health Authority Ministry of Health and Welfare (hereinafter, the “MOHW”) pre-announced on August 3rd, 2021 a draft amendment to the Regulations for Medicine Safety Monitoring (hereinafter, the “Draft”). The pre-announcement period for soliciting written opinions is 60 days (expired on October 2nd, 2021). A summary is as follows:
1. Management of medical devices shall follow the Medical Devices Act enacted on May 1st, 2021 instead of the Pharmaceutical Affairs Act, and the word “medicine” recited in the title is thus amended to “drug.”
2. Any entity holding Taiwan’s Western medicine permits (including biological products, bacteriological and immunological products, and rare disease drugs, etc.), new Chinese medicine permits, and announced or approved Chinese medicine permits shall conduct drug safety monitoring on their products during the effective course of the permit (Article 2 of the Draft).
3. The contents of a drug safety monitoring plan which are mandatory to pharmaceutical firms are set forth (Article 3 of the Draft).
4. Pharmaceutical firms shall report within 3 days if they have known any situation specified, and the MOHW may request the firms to conduct risk management measures (Articles 4 to 5 of the Draft).
5. Pharmaceutical firms for new drugs shall submit “regular drug safety reports” within 5 years from the date of the issuance of a drug permit (hereinafter, the “date of issuance”) and shall submit a “final drug safety report” at the expiry of the 5-years course. The MOHW may request subsequent reports after receiving the final drug safety report when necessary. For drugs with specific categories or ingredients, the MOHW may request pharmaceutical firms to establish a “drug risk evaluation and management plan” (Articles 6 to 8 of the Draft).
6. Submission of the regular and final drug safety reports, as well as the drug risk evaluation and management plan for pharmaceutical firms that closed permanently or temporarily, is set forth (Article 9 of the Draft).
7. Pharmaceutical firms shall preserve their drug safety monitoring data for five years after the permit expires. When the permit is transferred with registration, the pharmaceutical firm transferring the permit shall hand over all relevant documents, and the pharmaceutical firm receiving the permit shall continue monitoring and preserve data (Article 10 of the Draft).
8. Pharmaceutical firms shall cooperate or provide documents when a MOHW agent conducts an inspection for drug safety monitoring (Article 11 of the Draft).
II. Points to consider concerning the Draft
Only 6 articles are set up in the present Regulations including that pharmaceutical firms for new drugs shall submit regular drug safety reports to the MOHW within 5 years from the date of issuance, and pharmaceutical firms for announced or approved drugs designated to have a risk management plan shall submit tracking reports within the specified time period designated by the MOHW (Articles 2 to 4). However, the present Regulations lack detailed plans on drug safety monitoring. The Draft has a total of 14 articles, expanding its regulation on all drug permit holders in establishing drug safety monitoring mechanisms. Pharmaceutical firms shall compile the safety monitoring data and reports thereof in accordance with the MOHW’s regulations, which are planned to be enacted on January 1st, 2023. Pharmaceutical firms should understand the amendments as soon as possible and reserve time to adjust internal affairs accordingly.