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

Asia

India

WHO calls for action after Asia-made medicines linked to 300 deaths

Regulators must take immediate and coordinated action to stop the supply of contaminated over-the-counter cough syrups linked to the deaths of more than 300 children in countries including Indonesia and Uzbekistan, the World Health Organization has asserted. In recent months, WHO has issued three global medical alerts covering substandard liquid dosage drugs. While adverse events were first reported in The Gambia, the quality problems have their roots in Asia. Indian companies were listed as the manufacturers of cough syrups found in The Gambia and Uzbekistan.

Pakistan

DRAP issued Consolidated Guidance Document on Good Manufacturing Practices for Manufacturing Sites of Drugs

To ensures the quality of drugs and compliance with its Current Good Manufacturing Practice (cGMP), DRAP monitor the manufacturers to ensure compliance to minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.  These Good Manufacturing Practices are intended to make sure that a product is safe for use, and meet the prescribed standard of quality. Although the Drugs (Licensing, Registering & Advertising) Rules, 1976 under the Drugs Act, 1976 provides detail requirements on Good Manufacturing Practices (GMP), however, DRAP intended to provide a compiled GMP guidance document stipulating Drug Regulatory Authority of Pakistan’s (DRAP) expectations on GMP from pharmaceutical & biological drugs manufacturers.

Directions of Registration Board on Labeling Requirements of Drug Products to Comply Pharmacopeial Specifications for Dissolution Testing

Registration Board in its 323rd meeting observed that various USP monographs for drug products prescribe more than one dissolution tests and that the pharmacopoeia in such cases recommends that “When more than one Dissolution Test is given, the labeling states the Dissolution Test used only if Test 1 is not used.” Keeping in the USP labeling requirements narrated above and to comply to the Pharmacopeial specifications, the Board decided as under: “The manufacturer shall mention the dissolution test Number on the secondary packing / unit carton of product for dissolution tests No 2,3 or 4 as per requirement of USP otherwise it would be presumed that dissolution test No.1 shall be performed on the finished product.”

Malaysia

Malaysia Medical Device Authority (MDA) Updates Fifth Edition Guideline for Medical Device-Drug and Drug-Medical Device Combination Product

Malaysia Medical Device Authority (MDA) updated the Fifth Edition Guideline for Medical Device-Drug and Drug-Medical Device Combination Products. This guideline includes evaluation timeline by NPRA, adverse drug reaction and incident reporting, ancillary drug dossier requirement for medical device-drug combination product, application form for endorsement letter of ancillary component for the registration of combination product, incident reporting form for combination product.

Drug Registration Guidance Document (DRGD) third edition, fourth revision of NPRA

NPRA has published Drug Registration Guidance Document (DRGD) third edition, fourth revision. It includes updated requirements for full and abridged evaluation, fees, priority review, regulatory control of active pharmaceutical ingredients. Labelling requirements and licensing are also updated in this revision.

Singapore

HSA Shares Statistic on HSA’s Mean Screening Time and Applicant’s Mean Screening Response Time For New Application and Major variation Applications

HSA strives to complete the screening of the new and major variation applications in the shortest possible time. For the new and major variation applications accepted within the period of 01 Apr 2022 to 30 Sep 2022, the mean screening time taken by HSA were as following: 33.3 WD for New Drug Application (NDA), 29.0 WD for Generic Drug Application (GDA), and 20.2 WD for (Major Variation) MAV application respectively.

Japan

Ministerial Ordinance on Good Clinical Practice for Drugs

PMDA published ministerial ordinance on good clinical practice for drugs. This includes standards for clinical trial management, standards for conducting clinical trial, standards for documents submitted in Reexamination, standards for sponsoring clinical trial.

Saudi Arabia

SFDA Guideline on good pharmacovigilance practices version 3.1

SFDA published guideline on good pharmacovigilance practices version 3.1. In this guideline, responsibilities of the marketing authorization holder in relation to the qualified person responsible for pharmacovigilance in KSA, format and layout, requirement of lack of therapeutic efficacy reports are updated.

ROW

Australia

Changes applying to evaluation of new substances for listed medicines

The TGA has introduced Mandatory requirements for applications to vary the Permissible Ingredients Determination under section 26BD of the Therapeutic Goods Act 1989, and accompanying guidelines that effect from 1 February 2023 and only apply to new applications submitted from this date. These requirements specify what information, and how that information must be provided for an application to pass preliminary assessment and progress to the evaluation phase, consistent with other therapeutic goods application processes.

Turkey

Guidance on conditional regulatory authorization (immediate use approval) application and evaluation

The Turkish medicines and medical devices agency published guidance on conditional regulatory authorization (immediate use approval) application and evaluation. The purpose of this guide is to explain the procedures to be carried out regarding the applications and the evaluation of these applications for conditional licensing (Emergency Use Approval).

Guidelines for renewal of registrants for medicinal products for human use

The Turkish medicines and medical devices agency published guidelines for renewal of registrants for medicinal products for human use. The purpose of this guide is to determine the procedures and principles of the work and transactions to be carried out for license renewal.

Sri Lanka

NMRA Monthly fee for Medicines – Effective from 01/02/2023 to 28/02/2023            

Dollar rates are converted at the selling rate on last working day of the preceding month (31.01.2023) which was published by the Central Bank of Sri Lanka.  This includes processing fees, fees for additional data evaluation, clinical trials fee, fee for certificate of registration, fees for license, fees for other approvals, fees for analysis, fees for license to deal in medicines in retail pharmacies, wholesale establishments and transporting of medicines, fees for GMP.

Zimbabwe

Application for issue of a license for premises and to manufacture, pack drugs and allied substances

MCAZ published application form for license for premises and it should be submitted in triplicate. MCAZ published application for a license to manufacture the medicines and allied substances. MCAZ published application to pack medicines and allied substances such as antibiotics, or preparations of antibiotics, vaccines and sera, sterile preparations, hormones and steroid preparations, vitamin preparations, antineoplastic agents and immunosuppressant agents other than steroid preparations, narcotic medicines, psychotropic substances, genetic engineering, allied substances.

Requirements for closure of a premises

MCAZ published requirements for voluntary closure of premises. This includes requirements such as signed notification letter, stock transfer, stock donation, stock incineration, return original premises license, signed notification letter on a company letter head.

Zambia

Notice to pharmaceutical industry about submission of hard copy applications

Zambia medicines drug regulatory authority informs that effective 1st March 2023, authority will not receive hard copy applications for grant of marketing authorization, renewal, amendment, or variations to registered medicines. All applications shall be received through Integrated regulatory information management system (IRIMS).

Notice to all marketing authorization holders, local responsible persons

ZAMRA request all MAHs through their respective local responsible persons and authorized distributors to provide information on registered allied substances. The information should include details of applicant, product name, composition, dosage form, pack size. The information must be received no later than 30th April, 2023.

New Zealand

Medsafe updates overview of new and changed medicine regulation

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has released a new version of its overview of medicine regulation in the country. Medsafe published the document after carrying out a major review and restructuring of its advice on the approval of new and changed medicines. While large sections of the guideline remain unchanged, Medsafe has added a new, short section on how to submit an application or notification, explaining that applications must be sent electronically and outlining how to use an electronic file transfer system to share files. The transfer system enables the submission of applications, notifications and master files to the agency.

Guide to completing a New Medicine Application for Lower-Risk Medicines

Medsafe published this guide as a reference document to assist the applicants with putting together a New Medicine Application (NMA) for a lower-risk medicine. This includes instructions for using the form for an NMA – Lower Risk Medicines, Application form for an NMA – Lower Risk Medicines, determining the application category, application format.

Guideline on the regulation of therapeutic products in New Zealand

Medsafe published guideline on the regulation of therapeutic products in New Zealand. This guideline includes new medicine application procedures for higher risk, low risk and intermediate risk medicines, applications based on approved patent product and priority assessment of applications.