Page 108 - 2022 Taiwan Health and Welfare Report

▏Section 4 Management of Drug Safety
1. Drug safety monitoring in 2021: TFDA received 13,615 domestic adverse drug reaction reports, 75 domestic and foreign drug safety alerts, 220 COVID-19 vaccine safety alerts, 32 drug safety assessments, 5 drug risk communication forms.
2. In 2021, 203 drug injury relief applications were received, and 94 were approved, the approval rate vis 66.2% and NTD 19,074,357 in total.
▏Section 5 Management of Controlled Drugs
1. On June 10 and October 8, 2021, 4 items for control were promulgated, and the amended names for 2 items were listed.
2. As of the end of 2021, there were 16,737 institutions and business operators with controlled drug registration licenses and 63,102 practitioners with controlled drug prescription licenses.
3. In 2021, a total of 8,018 on-site inspections were conducted, with a 3.31% violation rate. Violators all received relevant penalties, handled as required by law.
4.To implement the "New-generation Antidrug Strategy," in 2021 we inspected 19,510 batches of drugs, with a total of 2,197 batches of active pharmaceutical ingredients (APIs) checked at the border using Portable Raman spectrometers, and the results were all compliant. We built the spectroscopic database in total of 2,191 items (including APIs, illegal drugs and controlled drugs, etc.) A total of 100 standards of illegal drugs and new substances were obtained, and 84 standard items were created in the mass spectrogram databases in 2021, while recommended test methods were actively developed.
5. Totally 108 lecturers have been trained by hosting seed instructor training and 8 anti- drug resource centers have been established in Northern, Central, Southern, and Eastern Taiwan cooperating with 127 outreach points to strengthen the drug abuse prevention and control network.
▏Section 6 Management of Chinese Medicine
1. The completion of validation procedures has been processed by 4 stages by pharmaceutical manufacturers producing concentrated Chinese medicines since January 1, 2020. In 2021, the MOHW guided 17 companies, and conducted 27 educational training courses. One Chinese medicine pharmaceutic factory has completed the first three stages and one the first two stages of validation operation checking.
2. 8 Chinese medicine pharmaceutic factories obtained NRICM 101 export -only license approved by the MOHW and were permitted to produce it domestically base on the "Approval of Specific Medicinal Products' Manufacturing or Importing as a Special Case".
3. On September 28, 2021, the promulgation of "the amended partial Regulations for Registration of Medicinal Products" loosens the regulations to promote Chinese medicine industry export to international markets.
4. On October 18, 2021, the promulgation of the "Regulations on Rewards and the Guarantee of Land Lease Period for the Lease of Public Lands or Lands owned by the State-owned Enterprises to Cultivate Chinese Medicinal Plants" encourages to plant Chinese medical herbals and guarantees the renting periods of lands.
5. Listed the trialed "internship for Chinese medicine education," "Chinese medicine internship instructor training and certification," and "selection of locations for Chinese medicine internship locations," for the reference of colleges planning Chinese medicine training courses.
6. The 4th edition of Taiwan Herbal Pharmacopeia was published on September 13, 2021. A total of 394 items including 355 monographs of Chinese medicine materials, 30 decoction slices of Chinese medicine materials, and 9 Chinese medicine preparations, and officially implemented on June 1, 2022.
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