Taiwan Clinical Trials | 台灣臨床試驗資訊平台

Q31

Is a GMP-related certificate required for registration of an API used in the pharmaceutical preparations?

Yes, according to Article 32 of the Regulations for Registration of Medicinal Products, the API used for pharmaceutical preparations should comply with GMP Guideline.

Q32

What are the requirements in specifications for the APIs that are not listed in the pharmacopeia?

For the requirements of the specifications for the APIs that are not listed in the pharmacopeia, please refer to the relevant contents of APIs in the ICH Q6A guideline. The general specifications of APIs include identification, assay, purity, and other analyses, e.g. appearance, crystal form, and particle size distribution. Among which, the identification of APIs, in principle, should include two methods based on different principles. In addition, the items of the purity tests should include impurities, residual solvents, heavy metals, water content, and total ash.

Q33

Can the application for registration of a domestic API and the application for DMF be submitted at the same time?

The applications can be submitted at the same time, and the fees for registration of API and DMF application should be paid upon submission of the applications. The certificate will be issued along with the license.

Q34

Is an application for post-approval change required for approved finished products if there is a change in API manufacturer? What information is required?

Yes, when the source of active ingredients apply for a change for the finished products, the following documents are suggested to be submitted according to Article 53 of Regulations for Registration of Medicinal Products:

The application form for post-approval changes;
Original copy of the product license;
GMP compliance certificate of the newly changed active ingredients;
The approval of the technical documents of the active ingredients issued by the central health competent authority;
Description of the differences of specification between the new and old source of active ingredient with evidential proof;
Comparison and evaluation data of the finished preparations according to the characteristics of the dosage forms;
According to the preceding paragraph, a dissolution test shall be conducted; if the comparison results of dissolution curves are dissimilar (f2<50), a BE test report shall be submitted.

Q35

Before obtaining the API license, can the API be purchased and used for manufacturing pharmaceutical preparations with drug licenses, and start selling the drug after the API license is granted?

According to Article 6 and Article 39 of the Pharmaceutical Affairs Act, the API can be manufactured into pharmaceutical preparations only after the API license is granted; in addition, based on Article 20 of the Pharmaceutical Affairs Act, the drugs manufactured without prior approval may be deemed as counterfeit drugs.

Q36

Which administrative documents need to be notarized by the R.O.C. foreign affairs offices for the registration of the imported APIs?

The Certificate of Pharmaceutical Product (CPP) and GMP certificates need to be notarized by the R.O.C. foreign affairs offices. For relevant regulations on GMP certificates, see the TFDA website: http://www.fda.gov.tw/TC/siteListContent.aspx?sid=301&id=9544&chk=d8fb8bd2-1d5c-40ee-b5ca-95cd0566c2fd¶m=pn%3d1%26sid%3d301#.VXVaPmdO6Um

Q37

Can the DMF certificate of the API replace submission of the closed part for the registration of APIs?

Yes, but the relevant administrative documents are still required.

Q38

If a DMF certificate has been issued for an API produced from a manufacturer, how should authorization be attained by another applicant for this DMF certificate?

The authorization letter issued by the original manufacturer should be provided. The authorized DMF approval number should be cited in the letter.

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