Category: Draft for Comments

Draft for Comment of Application for Labeling Compliance of Drug Products under Maximum Drug Retail Price

 All comments can be sent at [email protected]. Deadline of submission of comments shall be by 08 January  2021.

   I. BACKGROUND/RATIONALE

Rule 31, Section 1 of the Joint DOH-DTI-IPO-BFAD Administrative Order No. 2008-01 entitled the Implementing Rules and Regulations of Republic Act 9502 Otherwise known as the “Universally Accessible Cheaper and Quality Medicines Act of 2008” stipulated that every drug product that are subject to price regulation shall reflect the retail price which shall not exceed the maximum retail price. Executive Order No. 821 s. 2009 “Prescribing the Maximum Drug Retail Prices for Selected Drugs and Medicines that Addresses Diseases the Account for the Leading Causes of Morbidity and Mortality”, 5 drug molecules or 27 drug formulas are subjected to price regulation

By virtue of E.O. No. 104 s. 2020 “Improving Access to Healthcare through the Regulation of Prices in the Retail of Drugs and Medicines” the drug product under price regulation are further expanded to 122 drug molecules or 205 drug formulas. On 12 May 2020, in consideration to the COVID-19 pandemic, a Memorandum was released by the DOH for the compliance of labeling materials for MRP medicines until 02 June 2021.

To reduce the regulatory burden in the application and approval of the inclusion or update of the MRP or the Maximum Drug Retail Price (MDRP) statement to the labeling materials of drug products, this Circular is hereby issued.

Read more:-> Draft for Comments-Application of Labelling Compliance of Drug Product under Maximum drug retail price

Draft for Comment of Implementing Guidelines of Joint Department of Health (DOH) and Department of Agriculture (DA) Administrative Order No. 2020-001: Re-Adoption of Joint DOH and DA Administrative Order No. 2013-0026

All comments can be sent at [email protected] Deadline of submission of comments shall
be by 3 December 2020

  1. INTRODUCTION

 

Cognizant of the authority of the Food and Drug Administration (FDA) to call upon the assistance of any department, office or agency under Section 30, paragraph 5 of Republic Act (RA) No. 3720 as amended by RA No. 9711, a partnership was forged between FDA and the Department of Agriculture-Bureau of Animal Industry (DA-BAI) in the regulation of selected veterinary establishments, drugs, and products by virtue of the Joint Department of Agriculture (DA) and Department of Health (DOH) Administrative Order (JAO) No. 2013-0026: Rules on the Regulation of Veterinary Drugs and Products, Veterinary Biological Products, and Veterinary Drug Establishments. The JAO No. 2013-0026 was effective for five years, until its expiration last September 2018. The delegation of regulation of veterinary establishments and products under the jurisdiction of the FDA began way back in late 1990 through a JAO between the DOH and DA Secretaries.

Read more:-> Draft FDA Circular Implementing Guidelines of JAO DA-DOH 2020-0001 Version 2.2

 

 

Guidelines on Compliance with Section 35 (b) of Republic Act No. 11223 (Universal Health Care Act) by All Drug, Medical Device, Biological and Medical Supplies Manufacturers to Submit Reports on Disclosure of Financial Relationships with Health Care Providers and Health Care Professionals

All comments can be sent at [email protected].

  1. BACKGROUND

The 1987 Philippine Constitution declares that it is the policy of the State to protect and promote the right to health of the people and instill health consciousness among them.  Consistent with the national health policy, the President of the Philippines signed into law, on February 20, 2019, Republic Act No. 11223 (RA 11223), otherwise known as the Universal Health Care Act (UHC law), which was passed by the 17th Congress of the Philippines.  The provisions of the UHC law seeks “to progressively realize universal health care in the country through a systemic approach and clear delineation of roles of key agencies and stakeholders towards better performance in the health system and to ensure that all Filipinos are guaranteed equitable access to quality and affordable health care goods and services, and protected against financial risk.”

Under item b of Section 35 on Ethics in Public Health Policy and Practice, the UHC law mandates that “all manufacturers of drugs, medical devices, biological and medical supplies registered by the FDA shall collect and track all financial relationships with health care professionals and health care providers and report these to the DOH.”  On October 10, 2019, the Secretary of Health signed the Implementing Rules and Regulation (IRR) of the RA 11223, which included the IRR for Section 35. Declaration of financial relationships between manufacturers of health products and health care providers and professionals has public health importance and value. Clinical evaluation and approval of innovative health products, including formulation of regulatory policies, are more efficient when conflicts of interest are addressed and managed through transparency and disclosures.

Read more:-> DRAFT AO Financial Relationship Manufacturer and HCPs for Posting

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

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”