title: Development of the risk-based, phased-in approach for the international harmonization of the regulation of container closure systems for drugs in Taiwan.
abstract: The main concern for container closure systems of drugs is to ensure suitability for the intended use which is associated with issues regarding protection, compatibility, safety, and performance. Among various concerns, leachables may pose a safety hazard to patients, while risks might vary depending on the dosage form and the administration route. Stringent regulatory authorities such as the European Medicines Agency and the United States Food and Drug Administration have established risk-based regulatory requirements and published corresponding guidelines to facilitate implementation. Taiwan, a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, makes every effort to harmonize with international regulations and to strengthen protection of public health through regulatory controls. The aim of the present study was to investigate the regulatory framework and policies set by stringent regulatory authorities. The strategy proposed for the development of an eventual guideline was sent to the Taiwan Food and Drug Administration for decision. A risk-based, phased-in approach which was extensively discussed in the expert committee was proposed. The approach proposed herein could also serve as a starting point which is worth considered by other countries in which international harmonization is in process.
authors.affiliation: Center for Drug Evaluation, 3F, No.465, Sec.6, Zhongxiao E. Rd., Taipei 11557, Taiwan. Electronic address: chaemily@gmail.com.
authors.forename: Lin-Chau
authors.initials: LC
authors.lastname: Chang
authors.affiliation: Institute of Toxicology, College of Medicine, National Taiwan University, No.1, Sec.1, Jen Ai Rd., Taipei 10051, Taiwan. Electronic address: jjkang@ntu.edu.tw.
authors.forename: Jaw-Jou
authors.initials: JJ
authors.lastname: Kang
authors.affiliation: Center for Drug Evaluation, 3F, No.465, Sec.6, Zhongxiao E. Rd., Taipei 11557, Taiwan. Electronic address: csgau206@cde.org.tw.
authors.forename: Churn-Shiouh
authors.initials: CS
authors.lastname: Gau
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence* / Q000592:standards; D004340:Drug Contamination / Q000331:legislation & jurisprudence* / Q000517:prevention & control*; D004349:Drug Packaging / Q000331:legislation & jurisprudence* / Q000592:standards; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D004867:Equipment Design; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D061214:Patient Safety / Q000331:legislation & jurisprudence* / Q000592:standards; D011050:Policy Making; D011786:Quality Control; D018570:Risk Assessment; D013624:Taiwan; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
keywords: Packaging material; Quality; Regulatory; Safety