Page 105 - 2022 Taiwan Health and Welfare Report

Table 7-3 Amendment, and revision of drug administration Regulations or Guidance, 2021
Date
Title
Key Amendments
Jan 13
Promulgated "Guideline for Technical Document Requirements for granting Emergency Use Authorization of COVID-19 vaccines"
Amended Article 3, Article 4 and Article 5-1 of "Drug Injury Relief Payment Standard"
Source : Taiwan Food and Drug Administration
Explained the specific technical document of CMC, non- clinical and clinical document to be submitted by the COVID-19 vaccine developer applying for EUA of the vaccines.
Sep 1
The maximum amount of drug injury relief payment was increased from NTD 2 million to NTD 3 million for cases that have been determined to have resulted in death or disability due to adverse drug reactions to protect the rights of the public.
Sep 8
Promulgated "Regulations on Good Practices for Positron Emission Tomography Drug Dispensation"
In order to regulate the dispensation of positron emission tomography drugs in domestic medical institutions, we established relevant regulations for application procedures, drugs inspection, quality control standards, and supporting measures, to protect the medical rights of the public and to strengthen the quality of drugs.
Sep 14
Amended "Regulations for Registration of Medicinal Products"
Amended some Articles and Appendices in order to keep pace with the international drug management trend, cooperate with the electronic submission platform, simplify the review process, improve the quality of drugs, and keep medication safety.
Oct 7
Promulgated "Guidance on Donor Informed Consent of Cell and Gene Therapy Medicinal Products"
Explained the donor informed consent items, and that written consent should be acquired beforehand. It is not allowed to coercive or unduly influence the donor. The donor inform consent should also be approved by the IRB in advance.
103
07
Jun 10
Stipulated "Guidance on Donor Recruitment of Cell and Gene Therapy Medicinal Products"
Stipulated "Guidance on Technical Documents Requirements for Bridging Cell Therapy Medical Technique to Cell Therapy Medicinal Products"
Promulgated "Guidance for EUA Review and Efficacy Evaluation of COVID-19 Vaccines in Taiwan"
Explained the contents of the donor recruitment advertisement, the restrictions on the posting targets, the period of validity, and requires the advertisement approved by the Institutional Review Board (IRB) before posting.
Feb 9
For efficacy and safety data obtained from the Specific Medical Technique Regulations, the guidance describes the technical data that should be submitted to support subsequent applications for clinical trials or registration of cell therapy products.
Explained the key points of the EUA review and efficacy evaluation of the COVID-19 vaccines in Taiwan.
Jul 1
Management of Food and Drugs