کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5856010 1562126 2016 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Development of the risk-based, phased-in approach for the international harmonization of the regulation of container closure systems for drugs in Taiwan
ترجمه فارسی عنوان
توسعه روش رویکرد مبتنی بر ریسک برای هماهنگ سازی بین المللی تنظیم مقررات بسته بندی بسته های مواد مخدر در تایوان
کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری علوم محیط زیست بهداشت، سم شناسی و جهش زایی
چکیده انگلیسی


- The main concern for the container closure system for drugs was presented.
- The international trend of the regulatory considerations was discussed.
- A risk-based, phased-in approach for international harmonization was proposed.

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.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 77, June 2016, Pages 252-256
نویسندگان
, , ,