Go To Content
:::
Home
Sitemap
Contact us
Bilingual Glossary
中文版
Go
Your browser does not support JavaScript.
If the webpage function does not work properly, please open the browser JavaScript status.
Hot:
food additives,
Nutrition label,
Medicinal Products
Food
Drugs
Controlled Drugs
Medical Devices
Cosmetics
About Taiwan FDA
:::
Drugs
Scope & Definition
Registration
Law & Regulations & Guidance
Inspection
Post Marketing Surveillance
Science & Research
Statistics/ FAQ
:::
you are in:
Home
Drugs
Scope & Definition
Terms and Definitions Related
Terms and Definitions Related to Active Pharmaceutical Ingredients
Terms and Definitions Related
Terms and Definitions Related to Active Pharmaceutical Ingredients
【Update Date:
2019-01-24
】
unit:藥品組
Terms and Definitions Related to Active Pharmaceutical Ingredients
Active Pharmaceutical Ingredient-related:
1. Active Pharmaceutical Ingredient: The active matter or ingredient, obtained through physical or chemical treatment, or through biotech processes, usually intended for use in the production of drugs, biological preparations, or biotech products to exercise pharmacological effects in the diagnosis, treatment, or prevention of diseases or to affect the structure and functions of the body.
2. Mass production batch: A batch of products reflective of the production scale and equipment available at the time of application
3. Common Technical Document (CTD): The common technical document format stipulated by the International Conference on Harmonisation (ICH); it is meant to govern the materials submitted to the competent authority for review of drug registration so that they can be presented in a consistent format.
4. Declaration of No Change: A declaration provided by an applicant wishing to enclose the CEP document to apply for a lean review of the Drug Master File, meant to state that the enclosed materials are identical to those initially submitted to and approved by the European Directorate for the Quality of Medicines & HealthCare (EDQM).