Draft for Comments || Amendment to FDA Circular No. 2022-004 entitled “Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 Establishing Facilitated Registration Pathways for Drug Products including Vaccines and Biologicals” to include Generic Drug Registration Applications and update the list of Reference Drug Regulatory Agencies
All comments may be sent to [email protected]. The deadline for submission of comments is on 05 January 2024. In the continuous effort to streamline regulatory processes and adopt good […]
Draft for Comments || Rules and Regulations Governing the Issuance of Authorizations for Toys and Childcare Articles
The Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) is hereby circulating the draft of the attached proposed administrative order, provisionally entitled “Rules and Regulations Governing the […]
Draft for Comments || Submission of Position Paper/Comments on the Draft Administrative Order entitled “Implementing Guidelines on the Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration and Other Authorizations and Regulatory Services Repealing Administrative Order No. 50s. 2001, “Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs” and its Amendments
This refers to the public consultation on the FDA’s new schedule of Fees and Charges conducted virtually on 27 October 2023 and face-to-face on 29-30 November 2023. All concerned FDA […]
Draft for Comments || Further Regulatory Flexibilities for the Implementation of FDA Circular No. 2020-025 “Implementing Guidelines for DOH Administrative Order No. 2019-0019″
The Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) is circulating the draft on the proposed FDA Circular, provisionally entitled “Further Regulatory Flexibilities for the Implementation of […]
Draft for Comments || Guidelines on the Filing and Submission of Applications for the Licensing of Cosmetic Establishments through the Food and Drug Administration (FDA) eServices Portal System
The Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) is soliciting comments on the proposed FDA Circular, provisionally entitled, “Guidelines on the Filing and Submission of Applications […]
Draft for Comments || Updates and Amendments to the List of Banned and Restricted Pesticides and Ingredients in Household/Urban Pesticides
The Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) is soliciting comments on the proposed policy, provisionally entitled, “Updates and Amendments to the List of Banned and […]
Draft for Comments || Guidelines on the Use of the Food and Drug Administration eServices Portal System for the Initial Application of a Certificate of Medical Device Notification (CMDN)
All comments may be sent to [email protected]. The deadline for submission of comments is on 08 December 2023. I. RATIONALE Republic Act (RA) No. 9711, otherwise known as the “Food […]
Draft for Comments || Adoption of the Philippine National Standards (PNS) and its Recommended Code of Practices (RCP) for Processed Food Products as Technical Regulation
All concerned stakeholders may submit comments in MSWord format via email to [email protected] on or before 05 December 2023 using the format attached. Template for posting – MSWord Format I. […]
Draft for Comments || Guidelines on the Filing and Submission of Applications for the Licensing of Household/Urban Hazardous Substances (HUHS) Establishments through the Food and Drug Administration (FDA) eServices Portal System
The Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) is soliciting comments on the proposed FDA Circular, provisionally entitled, “Guidelines on the Filing and Submission of Applications […]
Draft for Comments || Recognition of Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring Services
All comments and recommendations shall be sent as a *.docx or *.pdf to [email protected]. The comment sheet may be accessed through the following link: http://wf26.2.vu/tsprecog/ I. BACKGROUND The Food and […]