EXTENSION OF DEADLINE TO SUBMIT ELECTRONIC COPY OF ALL REGISTERED DRUG PRODUCTS' DOSSIER

Please be informed that the Center for Drug Regulation and Research is extending the deadline for the submission of electronic copy of all registered drug products, pursuant to FDA Memorandum Circular No. 2013-023, from 30 September 2013 to 30 June 2014.


Submission requirements shall still follow Sec. 4, item 4.1 of FDA Memorandum Circular No. 2013-023. However, instead of using the DVD, a USB shall be used. The device will be returned to the Market Authorization Holder (MAH) once the dossier has been copied by FDA. Please take note that all data for the latest life cycle of a product must be submitted, i.e., for products existing for 12 years in the market, the 2nd renewal documents shall be submitted including any other documents (e.g. amendments, variations) submitted during its validity; for products existing for 4 years, the initial application documents shall be submitted including any other documents submitted during its validity. Please take note of the following documentary requirements for initial and renewal applications:

 

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