Table Of Contents (TOC) for TAIWAN

TAIWAN www.cde.org.tw/

Authority

CDE: Center for drug evaluation, National laboratories of F&D

website

http://www.nlfd.gov.tw/fail/SqlErr.htm?aspxerrorpath=/english/index.aspx

if any

REQUIREMENT FOR PRODUCT REGISTRATION

S.NO

CONTENTS

1.

Certificate of pharmaceutical product for manufacturing and sale

Valid period (two years)

Issued by the highest healthy authority and legalized by ROC foreign affairs officials or trading representatives.

The recorded formulation, dosages form, and contents should be consistent with those on the application form.

The record product name, the name and address of the manufacturer should be consistent with those on the application form.

The denotation of the pharmaceutical manufacturer and the permission of free sale in the country.

2.

Letter of authorization

Valid period ( one year)

Issued by the manufacturer

Name and address of the manufacturer/packager should be consistent with those on the application form.

Product name, dosage form, and content should be consistent with those on the application form.

Name and address of agents should be stated.

Technical documents

3.

Test specifications and methods (two copies of data on raw materials and finished product)

Test specification and method for raw material of each ingredient (including auxiliary material and coloring agents added in to the manufacturing process.)

4.

Certificate of analysis (two copies of data on raw material and finished product)

5.

The CoA and specification of each ingredients of the capsule dosage form including the pigment or dye.

6.

Critical manufacturing process validation report (two copies)

7.

Assay method validation report ( two copies)

8.

Sterilization validation (Non – sterile products can be exempted.)

The applied drug is classified as 

    0 Steam sterilization                 0 Dry heat sterilization

   0 Sterile filling                          0 Ethylene peroxide  

   0 Radiation sterilization            0 Others

   Standard operating procedure       - Results

9.

If the manufacturing site have inspected by the BFAD, please provide the inspection approval to waive the of critical manufacturing process validation report & assay method validation report

10.

Completed batch record or manufacturing in-process control procedures of the same batch as finished product

Batch size of  finished product and each ingredient

Manufacturing (mixing sequence, time, heating, sieving, etc.) and the entire manufacturing processs.

Controlling items and scopes (moisture content of granules, hardness, weight, thicknes, disintegration, PH, volume of filling, etc.)

Sampling methods (sampling frequency and size)

11.

Stability test

Standard operating procedure

Test results for three lots of marketed products have reached the claimed shelf life

Dossier submission : At least six months long term & accelerated stability data

By the time of license approval, the applicant must provide 12 months long term study report.