Article 1
These Regulations are established in accordance with Paragraph 2 of Article 45 of the Pharmaceutical Affairs Act (hereinafter referred to as the Act).
Article 2
The period designated by the central competent health authority as required by Paragraph 1 of Article 45 of the Act shall be based on the effective period shown on the Drug Permit.
Article 3
The pharmaceutical dealer holding a permit for pharmaceutical preparations (hereinafter referred to as the pharmaceutical dealer) shall monitor the safety of the pharmaceutical preparations within the periods specified in the preceding article.
The surveillance of pharmaceutical safety in the preceding paragraph shall cover the following:
1. The preparation of a pharmacovigilance plan indicated in Article 5 and reporting indicated in Article 6.
2. Collection of new drug safety data and submission of reports indicated in Articles 8 and 9.
3. The preparation of the risk assessment and control plan consisting of drugs of specific types or compositions,its implementation,and submission of the reports indicated in Article 10.
Article 4
Chinese medicines that meet one of the following conditions,are applicable under these Regulations:
1. New drugs as indicated in Article 7 of the Act.
2. Drugs announced or approved by the central competent health authority as required by Paragraph 1 of Article 10.
Article 5
The Pharmacovigilance Plan prepared by the pharmaceutical dealer shall cover the following:
1. Planning,operating,and managing the surveillance procedure.
2. Source of pharmacovigilance information and method of collection.
3. Evaluation and analysis of the information contained in the preceding sub-paragraph.
4. Risk management for drugs with safety concerns.
5. Responsibilities and functions of internal staff.
6. Planning and implementing pharmacovigilance training programs.
Article 6
In any of the following situations,the pharmaceutical dealer shall report it through the online system established by the central competent health authority within three days from the day of awareness of the situation:
1. Unexpected serious adverse drug reactions or serious adverse drug reactions occurs at a frequency that exceeds expectations.
2. It is required to evaluate new or altered contraindications or restricting use.
3. The drug is suspended or withdrawn from the market due to adverse reactions in A10 countries,which include Germany,US,UK,France,Japan,Switzerland,Canada,Australia,Belgium,and Sweden.
4. It is determined that it should be reported when a drug is suspended or withdrawn from the market due to adverse reactions in countries other than those in the preceding subparagraph.
Serious adverse drug reactions indicated in Subparagraph 1 of the preceding paragraph refer to those indicated in Article 4 of the Regulations for Reporting Severe Adverse Reactions of Medicaments.
Article 7
When drugs are found with one of the conditions under respective sub-paragraphs of Paragraph 1 in the preceding article,the central competent health authority may demand that the pharmaceutical dealer enforces the risk management below:
1. Release warnings or their equivalents.
2. Revise the package insert.
3. Submit the Drug Safety Report.
4. Suspend the use and sale.
5. Recall the product.
6. Other necessary measures.
Article 8
The pharmaceutical dealer shall submit the Periodic Drug Safety Update Report (See Appendix 1) to the central competent health authority within five years following the issuance of the Drug Permit for new drugs under Article 7 of the Act by the said authority and the Drug Safety Summary Report (See Appendix 2) upon expiration of the said Permit.
The data lock point (DLP) for the periodic report in the preceding paragraph shall be once every six months for the first and the second years following issuance of the Permit and once every year for the remaining three years.
The pharmaceutical dealer may enclose the following materials within three months from the next date upon receipt of the notification for picking up the Permit indicated in Paragraph 1 and apply with the central competent health authority for re-calculation of the DLP:
1. The international birth date (IBD) or the start date of the Periodic Safety Update Report (PSUR) approved by one of the A10 countries.
2. The planning of the DLP for the collection of data for the reports respective term reports. The interval between terms,however,shall not exceed one year.
The periodic and summary reports indicated in Paragraph 1 shall be submitted within 90 days of the expiration of the DLP for data of the respective terms.
Article 9
Upon receipt of the summary report indicated in Paragraph 1 of the preceding article,when it is considered necessary,the central competent health authority may demand that the pharmaceutical dealer continue to collect the data and submit the report as indicated in the preceding article for a designated period; such designation is not limited to once.
Article 10
The central competent health authority may announce or approve drugs of a specific type or composition and demand that the pharmaceutical dealer prepares the Risk Assessment and Control Plan (See Appendix 3) within three months following the date of announcement of approval and submit it to the central competent health authority for approval before it may be enforced.
The Plan in the preceding paragraph shall cover the methods of risk assessment and control,the deadline for submitting the report,and other matters to be implemented.
Changes to the Plan indicated in the preceding paragraph,if any,shall be submitted to and approved by the central competent health authority before they may be enforced,except for the following changes:
1. Name,address,correspondence site,telephone,or fax number of the pharmaceutical dealer or manufacturer.
2. Name or address of the distributor.
Article 11
In the event that the periodic and summary reports of drug safety indicated in Article 8 or 9 are not submitted or the Risk Assessment and Control Plan in the preceding article is not completely enforced as a result of the pharmaceutical dealer suspends business operations or going out of business,a report shall be submitted on the portion that is already completed within 60 days after the occurrence of facts of suspended or discontinued operation. Implementation shall be continuing upon restored operation in the future.
Article 12
The drug safety surveillance-related data defined herein shall be retained by the pharmaceutical dealer for five years after the expiration of the drug permit.
The data indicated in the preceding paragraph include the source data,files,documents,and publications needed to complete the said plan or report.
Once transfer registration is approved by the central competent health authority for a drug permit,the assignor shall hand over drug safety surveillance-related data to the assignee and the assignee shall continue with the surveillance effort and store the data as required herein.
Article 13
The central competent health authority may send personnel to inspect the drug safety surveillance process or request the provision of relevant data. The pharmaceutical dealer shall not evade,impede or refuse such inspection or request.
The central competent health authority may invite scholars,experts,or relevant agencies (institutions) to take part in the inspection or review of the data as indicated in the preceding paragraph.
Article 14
The plan and report defined herein shall be prepared in Traditional Chinese or English. When the appendixes are not in Traditional Chinese or English,their Traditional Chinese versions or English translations shall be prepared separately.
Article 15
When the pharmaceutical dealers need to collect,process,or utilize personal data in order to conduct drug safety surveillance,they shall follow the requirements of the Personal Data Protection Act and its relevant regulations.
Article 16
These revised Regulations shall comply with from January 1,2023.