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Additional Instruction for Letters, Commercial Samples, and Approved Labels for Post-Marketing Surveillance (PMS) Purposes to be Submitted to the Center for Drug Regulation and Research

Consistent with the issuance of FDA Memorandum dated 14 august 2014 regarding the Receiving of Product Application and Letter, and to facilitate the processing of related services and regulatory processes, all concerned stakeholders are requested to comply with the following additional instructions:

- For letters, kindly provide contact details (e.g. telephone number(s) and/or e-mail address(es). This will allow online viewing of the letter vial DocTrack at and minimize the need for the follow-up on the part of the stakeholder.

- For labels submitted as part of post-approval commitment, kindly include copies of the labeling materials as corrected by CDRR. This will facilitate the review and filling of the process of FDA.

- For commercial samples submitted as part of post-approval commitment, kindly include copies of the approved labeling material(s). This will facilitate the review and filling process of FDA.

As part of transparency and rendering faster processing of the above mentioned submissions, instead of issuing acknowledgement letters, FDA shall acknowledgement via DocTrack.

For your information and compliance

Download this file (announcement.pdf)announcement.pdf


Application for Registration of Raw Materials and Low Risk Pre-Packaged Processed Food Products

In accordance with FDA Circular No. 2014-0029 entitled "Procedure for the Use of Electronic Registration (E-Registration) System for Raw Materials or Ingredients and Low Risk Pre-packaged Processed Food Products," all low risk food products as listed in Annex A of attached AO2014-0029 and raw materials shall be applied online through electronic registration. Following the said circular, the Public Assistance Information and Receiving (PAIR) Unit shall no longer receive application for the raw materials and low risk food products.

For information and guidance

Download this file (ANNOUNCEMENT.pdf)ANNOUNCEMENT.pdf

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