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

Asia

Malaysia

Guide for ADR reporters

NPRA published guide for ADR reporters which included improving the quality of reports, checklist for ADR reporters. Guideline also includes laboratory testing for suspected adulterated products, accessing information on global ADR reports. Notice of the Center for Drug Evaluation of NMPA on the Applicability of E2B (R3) Regional Implementation Guide to Individual Case Safety Reports during Drug Clinical Trials In order to implement the E2B (R3) Regional Implementation Guide for Individual Case Safety Reports (hereinafter referred to as the Regional Implementation Guide), the Center for Drug Evaluation has completed the upgrade of the pharmacovigilance system during clinical trials, which was put into trial operation on January 1, 2022. Applicants shall complete the system configuration in a timely manner, and implement E2B (R3) in accordance with the Regional Implementation Guide no later than July 1, 2022.

Armenia

Variation guideline of Armenia

Republic of Armenia published detailed variation checklist for medicinal products. Prior to submission or examination of a variation whose classification is not provided for in this guideline, an Applicant may request the Scientific Centre to provide a recommendation on the classification of the variation. The recommendation will be delivered within 45 days following receipt of the request and sent to the Applicant.

India

G.S.R. 778(E) – Amendment to the New Drugs and Clinical Trials Rules, 2019

Ministry of health and family welfare published a draft of certain rules further to amend the New Drugs and Clinical Trials Rules, 2019. These rules may be called the New Drugs and Clinical Trials (Third Amendment) Rules, 2022. FORM CT-02A, FORM CT-06A, FORM CT-07A, FORM CT-11A, FORM CT-14A, FORM CT-15A were published.

Pakistan

Directions of Registration Board on Reference Product data submissions for conducting Pharmaceutical Equivalence and Comparative Dissolution Profile Studies

Registration Board of DRAP has issued a Guidance document for applicants on submission of application on form 5-F (CTD) for registration of pharmaceutical drug products for human use. Submission of data of pharmaceutical equivalence and Comparative Dissolution Profile (CDP) is required under section 3.2.P.2.2.1 (Formulation Development) of Form 5F (CTD).

Directions of Registration Board on the Drug Substance (DS) for Product Development, R&D, and Stability Testing

The Registration Board of Drug Regulatory Authority of Pakistan grants registration to pharmaceutical and biologicals drug products for human and veterinary use. The Drugs (Licensing, Registering and Adverting), Rules, 1976 as amended requires that applicant shall submit applications for human use on Form 5F (CTD), along with submissions of product development, and stability studies, etc under the relevant modules. For these studies, applicants firms have to procure the Drug Substance / Active Pharmaceutical Ingredient (API) from licensed pharmaceutical manufacturers only having valid Good Manufacturing Practices (GMP) Certifications and/or Drug Manufacturing Licenses form the relevant Regulatory Authority of the Country of origin.

Stakeholders Comments are invited on the Draft Guidelines on Good Manufacturing Practices (GMP)

Although the Drugs (Licensing, Registering & Advertising) Rules, 1976 under the Drugs Act, 1976 provides detail requirements on Good Manufacturing Practices (GMP), however, DRAP intends to provide a compiled GMP guidance document stipulating Drug Regulatory Authority of Pakistan’s (DRAP) expectations on GMP from pharmaceutical & biological drugs manufacturers. This draft guideline is uploaded on the official website of DRAP dated 5th January, 2023 seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to ajmal.sohail@dra.gov.pk, copying at hasan.afzaal@dra.gov.pk, or can be posted at mailing address, Additional Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

ROW

Tanzania

Payment of annual retention fees for the year 2023 in Tanzania

The Tanzania Medicines and Medical Devices Authority wishes to remind its esteemed Customers that as per Section 55 (b) of the Tanzania Medicines and Medical Devices Act, Cap 219, the retention of products in the Register of Registered Products is upon payment of a prescribed fee. The Retention Fee is required to be paid by 31st of January of each calendar year as prescribed in the TMDA Fees and Charges Regulations, 2021. After 31st January 2023, Import Permits will not be issued to any product for which its Annual Retention Fee is not paid. All companies are required to collect the respective invoices from TMDA Eastern Zone Offices (located at Off Nelson Mandela Road, Mabibo External, P.O. Box 77150, Dar es Salaam) or TMDA Headquarters (located at Plot No. 56/1. Block E, Swaswa Road, P.O. Box 1253 Dodoma) and pay the annual retention fees for the calendar year, 2023 before the 31st January 2023.

A checklist for screening of applications for registration of human medicinal products before their submission in Tanzania

To ensure the complete submission of information/data, the Authority has prepared a checklist which can be used by applicants to screen applications before their submission. The checklist provides oversight assurance to the manufacturer and as well as TMDA that the information provided is complete in line with the applicable guidelines and henceforth facilitates an efficient and effective assessment process. This checklist has been developed for guidance only to help the applicant to prepare and submit a complete product dossier and therefore should be read in conjunction with all relevant guidelines. Applicants should in all cases comply with requirements governing the registration of medicines in Tanzania.

Bahrain

Compliance with Use of the NHRA-MVC Traceability Hub for Pharmaceutical Product Traceability

As per Resolution No. 41 of the year 2017, and in reference to Circular No. (17) 2022 Use of the NHRA-MVC Traceability Hub for Pharmaceutical Product Traceability, all pharmaceuticals entering the Kingdom of Bahrain are subject to serialization in accordance with the National Health Regulatory Authority (NHRA) Medicines Barcoding and Serialization Guideline; Kingdom of Bahrain; May 2019 Version 1.2.

Saudi Arabia

SFDA Obtains Accreditation Certificate in Inspection of Drug and Medical Devices Facilities

​The Saudi Food and Drug Authority (SFDA) has obtained a certificate of accreditation in the field of inspection of food facilities, drugs and medical devices, in addition to renewing the accreditation for the fifth year in a row in inspection of food facilities in accordance with the international standard ISO/IEC 17020:2012. This standard is considered the basic standard for international accreditation bodies and the international standard recognized around the world in the field of inspection.

SFDA Guide to Good Manufacturing Practice for Medicinal Products Version 4.2

SFDA published guide to GMP for medicinal products version 4.2. In this guideline, manufacture of sterile medicinal products has been updated which is going to be implemented in 25 August 2023.