Page 93 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report Chapter 6. Early Warning, Monitoring and Risk Management

medicinal products in 2016.

D. Implementing risk management plans for medicinal products in pharmaceutical
companies
Since 2010, the system of Medicinal Product Risk Management Plans for
Pharmaceutical Companies was gradually established for medicinal products
with specific risk concerns. Pharmaceutical companies and medical institutions
are required to work together in order to implement various risk control tools
such as patient drug usage instructions, medical staff notification, and special
preventive measures. Follow-up assessments of implementation effectiveness are
also carried out regularly to ensure the public's drug use safety. Risk management

plans are required for bisphosphonates medications, third-and fourth-generation
combined oral contraceptives, anti-epileptic drugs that contain carbamazepine,
TNF-alpha blockers and acne medication with cyproterone acetate and
ethinyloestradiol.
E. Risk communication
In 2016, a total of 301 domestic medicinal products recalls, 26 global drug quality
alerts, 12 risk communication letters and 4 newsletters of medicinal product safety

were announced to remind the public and medical staffs of the safety or quality
alerts of medicinal products.

(3) Training of risk assessment professionals
In 2016, TFDA held a total of 15 seminars advocating the reporting of ADRs
and defective products for health professionals, health bureaus and departments,
pharmaceutical companies, and members of the public. TFDA also worked with the
Taiwan Pharmacy Forum to provide free online courses in order to promote reporting
of ADRs. Moreover, TFDA also held six training courses for pharmaceutical

company personnel responsible for drug safety monitoring in order to help the
companies establish safety monitoring and risk management systems.

2. Controlled drug alert monitoring and abuse prevention
Drug abuse is becoming an increasingly global and complex challenge. TFDA
summarizes and analyzes national drug abuse trends, provides cross-departmental
database integration of drugs and drug abuse reporting system and big data of drug abuse

analysis as references for drug abuse control strategies.

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