Category: Draft for Comments

Draft Guidelines on Facilitated Registration of Drugs Products, Vaccines and Biologicals: Abridged Review, Verification Review, and Collaborative Procedure

All comments can be sent at [email protected]. Deadline of submission of comments shall be by 28 August 2020.

  1. OBJECTIVES

The general objective of this Administrative Order is to provide facilitated registration procedure and review process of drug products, including vaccines and biologicals.

Specifically, this Administrative Order aims to:

  1. Provide registration procedures for market authorization holders (MAH) of drug products holding current approval from reference drug regulatory agencies and prequalification/ registration;
  2. Participate in the global or regional collaborative procedures for accelerated registration;
  3. Identify the reference drug regulatory agencies as the basis for an abridged and verification review registration procedure; and
  4. Establish strategic assessment and evaluation process of drug products that already passed stringent regulatory approvals from foreign drug regulatory agencies.
  1. SCOPE AND COVERAGE

This Order shall apply to all MAH of drug products holding current approval/s from reference drug regulatory agencies and/or registered under the collaborative registration procedures.

Read more:->Draft AO on Facilitated Registration Procedure v1.3.1

/ In Draft for Comments / By Administrator / Comments Off on Draft Guidelines on Facilitated Registration of Drugs Products, Vaccines and Biologicals: Abridged Review, Verification Review, and Collaborative Procedure

Draft for Comments of Implementing Guidelines for Imported Pharmaceutical Products from a Foreign Trader

All comments can be sent at [email protected]. Deadline of submission of comments shall be by 21 August 2020.

  1. OBJECTIVES

This Circular aims to:

  1. Provide guidelines to reflect the actual manufacturer of drug products;
  2. Provide guidelines for all renewal, compliance, MR to Initial Applications which were disapproved due to non-submission of the Foreign current Good Manufacturing (cGMP) Clearance due to the reflected manufacturer is a loan license manufacturer; and
  3. Provide guidelines to all pending and incoming registration of drug products having a foreign trader.

Read more:-> Draft for Comments of Imported Pharmaceutical Products from a Foreign Trader

FURTHER EXTENSION OF DEADLINE OF COMMENTS OF DRAFT FDA CIRCULAR ON IMPLEMENTING RULES AND REGULATIONS ON REVISED APPLICATION PROCESS AND REQUIREMENTS FOR POST-APPROVAL CHANGES OF PHARMACEUTICAL PRODUCTS, AND INSTITUTIONALIZATION OF THE PHILIPPINE VARIATION GUIDELINES, AND PHILIPPINE VARIATION GUIDELINES VERSION 1.0

In the interest of public service, the submission of comments on the subject draft FDA Circular is further extended from 14 August 2020 to 24 August 2020.

All comments shall be sent at [email protected].

For your information and compliance.

Attachment:-> Deadline Extension for Draft for Comments
Attachment:->Draft Circular for Post Approval Changes and PVG
Attachment:->Philippine Variation Guidelines V.1.0 with fees and charges

/ In Draft for Comments / By Administrator / Comments Off on FURTHER EXTENSION OF DEADLINE OF COMMENTS OF DRAFT FDA CIRCULAR ON IMPLEMENTING RULES AND REGULATIONS ON REVISED APPLICATION PROCESS AND REQUIREMENTS FOR POST-APPROVAL CHANGES OF PHARMACEUTICAL PRODUCTS, AND INSTITUTIONALIZATION OF THE PHILIPPINE VARIATION GUIDELINES, AND PHILIPPINE VARIATION GUIDELINES VERSION 1.0

Procedure for the Use of the New Electronic Registration System Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration (E-Registration) System for Prepackaged Processed Food Products”

Please be informed that the subject draft contains an additional section for review/comments, Annex Dentitled Reference Guide to Stakeholders to Assess Compliance of Submitted Documents as Complete Requirements for Product RegistrationThe date of effectivity of the guidelines was moved to 15 September 2020.

This Office is therefore extending the web posting period of the subject draft for your review of Annex D, hence kindly submit your comments (if any) in MSWord (docx) format until 25 August 2020 by email to [email protected] with copy furnished to [email protected] using the format below:

Name of Organization
Contact Information

Telephone:                                                                              E-mail:

Title of draft policy (FDA Circular):

Procedure for the Use of the New Electronic Registration System Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration (E-Registration) System for Prepackaged Processed Food Products”

Section Comments Input / Recommendation
Suggested Text (if any)

Thank you.

Attachment:->Draft Procedure for the Use of the New Electronic Registration System
Attachment:->Annex D

/ In Draft for Comments / By Administrator / Comments Off on Procedure for the Use of the New Electronic Registration System Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration (E-Registration) System for Prepackaged Processed Food Products”

EXTENSION OF DEADLINE OF COMMENTS OF DRAFT FDA CIRCULAR ON IMPLEMENTING RULES AND REGULATIONS ON REVISED APPLICATION PROCESS AND REQUIREMENTS FOR POST-APPROVAL CHANGES OF PHARMACEUTICAL PRODUCTS, AND INSTITUTIONALIZATION OF THE PHILIPPINE VARIATION GUIDELINES, AND PHILIPPINE VARIATION GUIDELINES VERSION 1.0

To provide sufficient time for comments on the subject draft FDA Circular, submission of comments is hereby extended from 5 August 2020 to 14 August 2020.

All comments shall be sent at [email protected].

For your information and compliance.

Attachment:->Philippine Variation Guidelines V.1.0 with fees and charges
Attachment:->Draft Circular for Post Approval Changes and PVG

/ In Draft for Comments / By Administrator / Comments Off on EXTENSION OF DEADLINE OF COMMENTS OF DRAFT FDA CIRCULAR ON IMPLEMENTING RULES AND REGULATIONS ON REVISED APPLICATION PROCESS AND REQUIREMENTS FOR POST-APPROVAL CHANGES OF PHARMACEUTICAL PRODUCTS, AND INSTITUTIONALIZATION OF THE PHILIPPINE VARIATION GUIDELINES, AND PHILIPPINE VARIATION GUIDELINES VERSION 1.0

FDA Citizen’s Charter for Comments

Please see the following Drafts for Comments of FDA Citizen’s Charter:

Please email your comments at [email protected].

Deadline for accepting comments will be on 18 August 2020.

DRAFTS FOR COMMENTS OF ADMINISTRATIVE ORDER “ADOPTION OF THE COLLABORATIVE PROCEDURE FOR THE ACCELERATED REGISTRATION OF WORLD HEALTH ORGANIZATION (WHO) – PREQUALIFIED DRUG PRODUCTS AND VACCINES”

Please see the following drafts for industry comments:

All comments can be sent at [email protected]. Deadline of submission of comments shall be by 14 August 2020.

/ In Draft for Comments / By Administrator / Comments Off on DRAFTS FOR COMMENTS OF ADMINISTRATIVE ORDER “ADOPTION OF THE COLLABORATIVE PROCEDURE FOR THE ACCELERATED REGISTRATION OF WORLD HEALTH ORGANIZATION (WHO) – PREQUALIFIED DRUG PRODUCTS AND VACCINES”

Draft for Comments of Implementing Rules and Regulations on Revised Application Process and Requirements for PostApproval Changes of Pharmaceutical Products, and Institutionalization of the Philippine Variation Guidelines and Philippine Variation Guidelines V.1.0

All comments can be sent at [email protected]. Deadline of submission of comments shall be by 5 August 2020.

Please see attachments:

Attachment:->Draft Circular for Post Approval Changes and PVG
Attachment:->Philippine Variation Guidelines V.1.0 with fees and charges

/ In Draft for Comments / By Administrator / Comments Off on Draft for Comments of Implementing Rules and Regulations on Revised Application Process and Requirements for PostApproval Changes of Pharmaceutical Products, and Institutionalization of the Philippine Variation Guidelines and Philippine Variation Guidelines V.1.0

Guidelines for the Use of the FDA eServices Portal System for License to Operate (LTO) Applications Pursuant to Administrative Order (AO) No. 2020-0017

OBJECTIVE:

The objective of this Circular is to provide guidelines for the use of the new FDA eServices Portal System for LTO applications of Drug Distributors (Drug Wholesalers, Exporters, and Importers), Drug Traders, Drug Retailers (Drugstores and RONPD), CRO, and Sponsors.

Please email your comments at [email protected] . Deadline for accepting comments will be on 10 August 2020 until 12:00 PM.

Attachment:-> Draft Guidelines for the Use of the FDA eServices Portal for LTO Application

/ In Draft for Comments / By Administrator / Comments Off on Guidelines for the Use of the FDA eServices Portal System for License to Operate (LTO) Applications Pursuant to Administrative Order (AO) No. 2020-0017

Procedure for the Use of the New Electronic Registration System Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration (E-Registration) System for Prepackaged Processed Food Products”

OBJECTIVE:

The Circular aims to provide detailed guidance on how to apply for and obtain CPR using the new E-Registration System.

to continue reading, click here…->https://bit.ly/3939bc0

SEE ALSO : FDA Circular No. 2016-014

/ In Draft for Comments / By Administrator / Comments Off on Procedure for the Use of the New Electronic Registration System Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration (E-Registration) System for Prepackaged Processed Food Products”
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