Page 127 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

Date Title Summary
Promulgated the Holders of drug permit licenses (with the exception of APIs) must list the ingredient
requirement that medicinal or name of the excipient on the package insert before December 31, 2015. Those
June
product package inserts that fail to do so before the deadline shall be subject to a ?ne of no less than NT$
29
must list the ingredient or 30,000 and no more than NT$ 150,000 for violating Article 75 of the Pharmaceutical
name of the excipient Affairs Act.
Promulgated standards for Part IV - Annex 1 Key Results and Statistics
Referenced management regulations from countries with well-developed medical
July the registration and review
fields to describe current review considerations for these type of products to
13 of human cell therapy
ensure product quality, safety, and therapeutic ef?cacy.
products
Promulgated the GMP for To safeguard public drug use safety and establish a comprehensive drug supply
July Modern Pharmaceutical chain, the MOHW promulgated the GMP for Modern Pharmaceutical Products (Part
16 Products (Part 3: 3: Distribution) to provide suppliers with relevant operational standards.
Distribution)

Promulgated the By January 1, 2016, all existing permits for preparations must attach evidentiary
implementation and documentation demonstrating compliance to API GMP and records for the sources
July schedule for GMP of the API (including name, address, and country of origin of the manufacturing
31 Compliance for Active site). Permits that do not involve production or imports currently do not require API
Pharmaceutical Ingredient source registration, but must attach relevant data and submit them to the MOHW
(API) of Preparations as an af?davit for the lack of production or imports.
The Regulations for Medicament Recall were promulgated to improve medicament
Promulgation of
August recall procedures, increase the responsibilities of medicinal product manufacturers
the Regulations for
5 and importers, and minimize public exposure or access to problematic
Medicament Recall
medicament.
Promulgated revisions
to the Guidelines for the
September preparations of radioactive Revised speci?cations for preparing PET scans in hospitals in order to improve the
4 isotopes for position quality of medicinal products and safeguard public drug use.
emission tomography
(PET) scan
Promulgated the guidelines
To eliminate risks of genetic disorders of human cell therapy products for cellular or genetic
for the process of
October therapy, the guidelines were promulgated to describe the criteria for determining the
determining the adequacy
5 adequacy of the donors, including the use of screening and tests for communicable diseases
of donors of human cell
and their pathogens.
therapy products
Manufacturing sites of biopharmaceuticals are often changed or added during the
Of?cial notice that allows process of development or after receiving approval for market release for the purpose
October biopharmaceutical permits of improving production scale and stability of product supply. The MOHW referenced
19 to be published for one or international speci?cations, collected opinions from various segments of society, and
more manufacturers held many discussions. Meeting resolutions were used to build a consensus to enact
revisions which were then publicly noti?ed through of?cial letters.
Formulated which data and information that must be submitted for review at
Promulgation of the
different phases of the clinical trial, allowing new drug researchers and developers
November Clinical Trials for Medicinal
to have a clear understanding of data or information that they must provide to enter
2 Products - Guidelines for
the next phase of clinical trials, thereby helping to improve the ef?ciency of new
Technical Documents
drug development processes.
Revised the penal provisions, established a traceability system for medicinal
products, established a system to report inadequate supplies of required drugs,
Revised a number
December provided supplementary provisions to improve the ease of reading medicinal
of articles of the
2 product information, established project approval systems in response to
Pharmaceutical Affairs Act
emergency requirements, and clearly included the sources of API within the
Regulations for Registration of Medicinal Products.
Monoclonal antibodies can be used to treat a wide range of illnesses that range
Promulgated Standards from immune system disorders to cancer therapy, necessitating the establishment
December for the registration of of scienti?c strategies and review principles. These standards were established by
4 monoclonal antibody referencing international speci?cations to describe current review principles and
biosimilars key considerations for monoclonal antibody biosimilars of the MOHW, providing a 125
reference for the research and development of this type of medicinal product.