Pharma/Biotech – Asia, ROW Regulatory News, Oct. 2023 Vol. 2

ASIA

Pakistan

DRAP outlines pharma implications of Pakistan’s hazardous waste policy

The Drug Regulatory Authority of Pakistan (DRAP) has shared information about how national guidelines on the environmentally sound management of solid and hazardous waste will affect the pharmaceutical industry. Pakistan’s Ministry of Climate Change released the National Hazardous Waste Management Policy, 2022, last year as part of its work to help the country meet its obligations under an international convention and achieve United Nations Sustainable Development Goals. The policy covers actions to control the movement of hazardous waste across borders, the management of contaminated sites and more.

DRAP details actions to improve pharmacovigilance reporting amid ongoing lack of centers

DRAP has outlined the steps it is taking to strengthen pharmacovigilance activities, reacting to slow uptake of new rules adopted in April 2022. Officials discussed the current situation at a recent meeting of the Pharmacovigilance Risk Assessment Expert Committee. Almost 18 months after DRAP adopted rules on reporting adverse events, only Punjab and Islamabad had established their pharmacovigilance centers. The World Health Organization has developed plans for the establishment of “vibrant pharmacovigilance centers.”

DRAP finalized the 2nd Edition of Guidelines on Post-Registration Variation of Drug Products

DRAP has finalized the second edition of its guidelines on procedure and data requirement for post registration variation of drugs. Registration / Marketing Authorization holders are responsible for the safety, efficacy, and quality of drug products that are placed on the market throughout their approved life cycle. These guidelines are intended to provide information for submission of post-registration variation application by the registrations / marketing authorization holders of drug products. It includes categories of variations and the required documentation & procedures for submission of an application for a particular variation.

Singapore

HSA outlines response to API proposal, responds to frequent questions

Singapore’s Health Sciences Authority (HSA) has responded to questions raised during the recent public consultation into upcoming changes to the regulation of APIs. HSA released draft legislation for consultation in July. The consultation attracted 59 comments from 16 parties, all bar one of which was a representative of the pharma industry. The top three types of feedback were requests for clarification on the licensing and regulatory requirements, the duties of licensees, and the transition approach, application process and fees.

Implementation of Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) manufacturers

The implementation will apply prospectively to New or Generic Drug Applications (NDA/GDA) and Minor Variation Applications (MIV-1) for addition of a new DS manufacturer. Effective 1 October 2024, NDAs, GDAs, and MIV-1 applications (Addition of new DS manufacturer) are to be supported by the required GMP Compliance Evidence for DS manufacturers. Applications submitted on or after 1 October 2024 without the required GMP evidence will not be accepted.

Philippines

FDA Advisory No.2023-2239 || Effectivity of FDA Circular (FC) No. 2023-008, entitled, “Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System

This is to inform all Marketing Authorization Holders (MAHs) of drug products and other concerned stakeholders that FDA Circular (FC) No. 2023-008 entitled “Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System” was published on a newspaper, The Manila Times, on 11 October 2023, thus, shall be effective on 26 October 2023. In line with the effectivity of the FC, MAHs of all existing registered drug products shall submit the latest approved facsimile/soft copy of Package Insert (PI) and Patient Information Leaflet (PIL) through email at cdrr.label@fda.gov.ph

Malaysia

Directive for the use of the Drug Registration Guidance Document (DRGD) Third Edition, Sixth Revision October 2023

NPRA has published Drug Registration Guidance Document (DRGD) Third Edition, Sixth Revision in October 2023. This “DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)” will serve as the reference guide for the registration process including quality control, inspection & licensing and post registration activities of medicinal products.

ROW

Australia

TGA calls for cautious off-label use of baclofen after spasm drug is implicated in two deaths

Australia’s Therapeutic Goods Administration has asked physicians to use caution when prescribing the muscle spasm drug baclofen off-label. The drug is indicated in the suppression of muscle spasms in patients with multiple sclerosis and certain spinal lesions. However, baclofen is also used off-label to treat conditions including musculoskeletal pain, gastroesophageal reflux disease and alcohol-use disorder. The drug is associated with complications and can be abused. TGA called for caution when prescribing baclofen off-label after “recent coronial inquiries into two deaths have highlighted the need for health professionals to be alert to the well-documented risk of overdose with baclofen.” The risk of intentional and unintentional overdose is “particularly pronounced” when the drug is used off-label at higher doses for alcohol-use disorder.

Submitting data in the eCTD format

TGA published guidance on how to submit data in the electronic Common Technical format. This information is for sponsors and manufacturers wanting to submit data in the electronic Common Technical Document (eCTD) format. Minor edit for clarification on naming convention of submission file.

Sri Lanka

GMP certificates validity period extension for Medicines (only for the category B)

As per the announcement published on 25.08.2023 at NMRA official website, applicants are informed to submit following documents.1. Request letter for the certificate extension,2. Original GMP Certificate,3. Copy of the latest GMP report. Applicant can submit above mentioned documents on every Monday at the dossier accepting point to the manufacturing regulatory division’s officials.

South Africa

Medicines Online Directory Toolkit

SAHPRA has launched an Online Medicines Directory. The Online Medicines Directory has been launched for Schedule 0-2. The job is to increase awareness and use of the directory amongst consumers, patients and healthcare providers. This toolkit provides Market Authorisation Holders (MAH) and SAHPRA activation guidance. In order to promote transparency, both are included here.

Switzerland

Changes and approval extensions HAM, ZL300_00_003 version 18.1

Swissmedic published Changes and approval extensions HAM, ZL300_00_003 version 18.1. Basic information, address, special procedures, additional forms to be submitted are included in this form.

Application for EpG laboratory operating license, I-302.AA.03-A15d Version: 3.0

Companies that carry out microbiological tests to detect or rule out communicable human diseases require an operating license from Swissmedic. These instructions serve as assistance in submitting the relevant application forms and contain additional information on the requirements for these companies. Requests for approval and reports of changes will be processed exclusively on the basis of the corresponding and completely completed forms. These must be from those for the company Persons authorized to sign (basic form) and by the technically responsible laboratory managers (additional sheet) must be signed and submitted to Swissmedic by post.

Manufacture and marketing of formula medicines, I-SMI.TI.24d Version 3.0

The guideline is aimed at the cantonal inspectorates with the aim of ensuring uniform inspection practices in the Swiss inspection system in accordance with Article 63 of the AMBV. It is the technical basis for the inspections under the medicinal products law, which are carried out by the cantonal inspectorates and Swissmedic.

FDA Slaps Switzerland’s UCB Farchim with Form 483 Over Quality Deficiencies

The FDA has smacked UCB Farchim for quality control lapses, among other deficiencies, following an inspection of its Bulle, Fribourg, Switzerland facility in June and July.