Regulation of Pharmaceuticals, Firm Types, Requirements, Methods, & Schedules - Western Pharma GDP

Taiwan Food and Drug Administration (TFDA) updated the pharmaceuticals enforcement including the pharmaceutical firm types, requirements, methods, and schedules regulated under “Western Pharmaceuticals Good Distribution Practice (GDP) Regulations”.

Pharmaceuticals and Pharmaceutical Firms who implemented Western Pharmaceuticals Good Distribution Practice Regulations are obligated to obey the following official announcements from the Ministry of Health and Welfare:

• 11 September 2018: Implementation Items and Schedules for the Western Pharmaceuticals Good Distribution Practice Regulations”

• 10 May 2019: Pharmaceuticals and the Types of Pharmaceutical Firms, Requirements, Methods, and Schedules Regulated under ‘Western Pharmaceuticals Good Distribution Practice Regulations – Western Pharmaceuticals Requiring Cold Chain Storage and Transportation’

• 27 July 2020: Pharmaceuticals and the Type of Pharmaceutical Firms, Requirements, Methods, and Schedules Regulated Under ‘Western Pharmaceuticals Good Distribution Practice Regulations – Active Pharmaceutical Ingredients’

Any pharmaceuticals, and pharmaceutical firms that have not implemented the Western Pharmaceuticals GDP Regulations yet, shall obtain the Western Pharmaceuticals distribution license,

(I) By 30 June 2024, if :

• The pharmaceuticals or pharmaceutical firms obtained the authorization of importation/exportation of western pharmaceuticals with the western pharmaceutical permit license, or,

• The pharmaceutical firms run wholesale activity of plasma derivatives, vaccines, or botulinum toxins that do not require cold chain storage and transportation

(II) By 31 December 2024, if :

• The pharmaceutical firms run the wholesale activity of pharmaceutical products other than plasma derivatives, vaccines, or botulinum toxins

• The pharmaceutical firms run the wholesale activity of western pharmaceutical products stated in Paragraph 2, Article 3, Controlled Drugs Act

• The pharmaceutical firms run the wholesale activity of pharmaceutical products referred to Article 27-2 of the Pharmaceutical Affairs Act

(III) By 31 December 2025, if :

• The pharmaceutical firms run the wholesale activity medicines to be prescribed by physicians of, referred to Paragraph 2, Article 8, Pharmaceutical Affairs Act and Article 3 of Enforcement Rules

• The pharmaceutical firms supply western pharmaceutical products to more than 10 wholesale dealers from 1 October 2024 until 31 December 2024

(IV) By 31 December 2026, if the pharmaceutical firms are involved in the activity of wholesaling, importing, or exporting the western pharmaceutical products that are not stated above.

(V) The western pharmaceutical distribution license applied from the aforementioned firms is accepted starting from the announcement date.

Kindly remember that the distribution license issuance will be subjected to the inspection of the quality system by the central competent health authority.

Source: Taiwan Food and Drug (TFDA)

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