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28

2014 Annual Report

Table 3-1 Revisions and additions to regulations governing the management of

pharmaceutical affairs, 2013

Publication

date

Regulation/specification

Summary

January 31 Regulations for Bioavailability and

Bioequivalence Studies

Amendments of article 15, 17 and 21, which

included the cross-over design of BA/BE

studies, the data exclusion criteria, and the

description of using basket/paddle methods

during dissolution tests

February 23 Guidance for Investigational New

Drug Applications

Any new drug clinical trial application must

fulfill the current requirement.

March 11

Revision for the set up standard

for new pharmaceutical

manufacturing factory, Amendment

for Standards for Medicament

Factory Establishments

and Pharmaceutical Good

Manufacturing Practice

Regulations

Combine Part 3 for

Good Manufacturing

Practices for Pharmaceuticals

and Part

4 as

Good Manufacturing Practices for

Medical Devices

of the set up standard for

new pharmaceutical manufacturing factory,

and then transferred without modification

to under the Part 2 and 3 sections for

the

Pharmaceutical Good Manufacturing Practice

Regulations

April 17 Guideline for Review and Approval

of Botanical Drug Products

The application and approval guidelines for

the botanical new drug products. A separate

regulation was issued to meet the distinctive

properties of the botanical drug products

April 18

Guideline for Review and Approval

of new chemical entities which

have been approved for over 10

years in the 10 advanced countries

This guideline lists the requirement of technical

document for marketing approval of drugs

which have been approved in the 10 advanced

countries for over 10 years, including new

chemical entity drug in Taiwan. There are

plenty clinical information for those drugs, the

publicly available information is accepted to

substitute for partial submission document

May 22

Announcement the Part 2, titled

as

Guide to Good Manufacturing

Practice for Medicinal Products

(Part II)

Provide GMP reference for manufacturers of

Active Pharmaceutical Ingredients, in Chinese

and English for the

Good Drug Manufacturers

Guidelines

May 29

Guideline for the Nonclinical

Pharmacology/Toxicology Studies

for Medicinal Products Applications

Removing outdated standards for physiological

values of laboratory animals and specific

pathogen-free experimental animals

Section 1 Product Regulations and Registration of Medicinal Products

Policy and Outcome

1. Comprehensive Standardized Regulation