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Guidance for cell therapy in Taiwan will be released in September
The Department of Medical Affairs, Ministry of Health and Welfare (MOHW) in Taiwan, announced that a new regulation for the implementation of cell therapy will soon be enacted this September.
By Joanne Shih
A draft revision of the Regulation for Specific Medical Technique and Device was released earlier this year in June 8. The regulatory document defines the usage of cell therapy in clinical application including medical indications and administrative guideline. After the release of the draft guidance, the MOWH received inquiries and suggestions from a wild range of medical professionals and experts in cell therapy. Thus, on July 17 the MOHW conducted a public briefing, inviting medical associations, industrial experts, and academic institutes to answer questions and concerns and to collect advices. The draft revision received positive feedbacks from attendees of that meeting, and will be reviewed by the regulatory committee in late August. An official regulation is expected to be released in September this year.
According to the Medical Care Act, clinical trial is prerequisite for all cell therapy to be used in clinical treatment, while the current regulation may cause delay in treatment for patients who may benefit from cell therapy. Therefore, the new guidance will be an adjustment to the Medical Care Act, allowing certain cell therapies that have already been tested by sufficient clinical trials, been successfully implemented in other countries, predictable effectiveness, confirmable safety, and low risk to be used in related medical indications. Some regulatory principles are listed below:
- Medical institutes should draw up treatment protocols for cell therapies, submit to supervisory institutes for approval, and register with municipal governments. Approved treatment protocols are valid for a certain period of time, and extensions should be submitted upon expiration. Medical institutes are obligated to submit annual report on implementation outcome to supervisory institutes. Termination of protocol could be issued if right and safety of patients are affected or any abnormality occurs.
- Executive physicians, medications, treatment plans, expenses and reimbursement methods, post-treatment follow up, template of informed consent, and remedies for potential adverse events should be indicated in treatment protocol for cell therapies.
- Procedures associated with cell processing, cell culture, and/or storage should be performed by certified facilities and trained personnels under the Good Tissue Practice (GTP) regulation. License for cell therapies execution is valid of a certain period of time, and extensions should be submitted upon expiration. Irregular inspections will be performed by the Ministry of Health and Welfare, and licenses could be retrieved if facilities fail to fulfill practice regulation.
- Medical institutes should create medical record dedicated to cell therapies aside from general medical records. If sever adverse events occur in patients who receive cell therapies, the incidents should be reported to supervisory institutes within 7 days.
In accordance with the revision of Regulation for Specific Medical Technique and Device, the Ministry of Health and Welfare will release guidances for education and training program for physicians, application procedure for medical institutes, and standardized formats for patient informed consent, application, and annual report. By enacting the new regulation, the MOHW is looking forward to seeing more cancer patients to be benefit from cell therapies under managed administration.
Reference
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