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MoH Ministry of Public Health MoH Website https://moph.gov.af/en Regulatory Authority Afghanistan Food and Drug Authority National Medicine and Health Products Regulatory Authority (NMHRA) Link for Regulatory Authority https://afda.gov.af/index.php/en/market-0 Afghanistan Drug Registration Procedure Pre-Market Afghanistan Drug Registration Procedure In the ever-changing healthcare landscape of Afghanistan, it is critical to effectively regulate medical goods and services. This paper explores the...

MoH  The Ministry of Health and Social Protection. MoH Website https://shendetesia.gov.al Regulatory Authority National Agency for Medicines and Medical Devices (AKPBM) Link for Regulatory Authority https://akbpm.gov.al/ Medicine/Drug/OTC/Pharmaceutical Registration in Albania The Agency for Medicinal Products and Medical Devices (AMPMD) is responsible for overseeing the drug registration process in Albania. Here is a general outline of the drug registration process: 1. Preparation of Documenta...

MoH Ministry of Health of Argentina MoH Website https://www.argentina.gob.ar/salud Regulatory Authority The National Administration of Drugs, Food and Medical Technology Link for Regulatory Authority https://www.argentina.gob.ar/anmat Applicable Regulation DECREE NO. 150/1992 ESTABLISHES THE RULES FOR THE REGISTRATION, PREPARATION, DIVISION, PRESCRIPTION, SALE, MARKETING, EXPORT AND IMPORT OF MEDICINES. Biologics/Drugs/Pharmaceutical/Medicine/OTC- General Registration Procedure and Requirement i...

MoH: Armenia Ministry of Health MoH website: https://www.gov.am/en/structure/1/ Regulatory Authority: Scientific centre of drug and medical technology expertise Link for Regulatory Authority: https://www.pharm.am/index.php/en/ Overview The registration of medicinal products in the Republic of Armenia involves adherence to a set of stringent requirements outlined in various legislative acts. The fundamental legal framework comprises the Laws of the Republic of Armenia, specifi...

Territory Southeast Asia  Official Language Indonesian/English  Regulatory Authority Name Badan Pengawas Obat dan Makanan (BPOM)  Regulatory Authority Website https://www.pom.go.id/   Mail ID halobpom@pom.go.id  Regulation Name Government Regulation No. 74 of 1996 on Pharmaceutical Affairs  Local Authorized Representative Yes  Classification of Medical Devices New Drug, Generic Drug, Biologic, Biosimilar.  Registration Timeline 3 to 12 months  License Validity 5 Years  Registration Fe...

The Indonesian Food and Drug Authority (BPOM) plays a crucial role in ensuring the safety and efficacy of pharmaceuticals within the Republic of Indonesia. In 2019, the BPOM made a significant stride towards enhancing public services and aligning regulations with the evolving landscape of medicine. Regulation Number 15 of 2019 amended the existing Regulation Number 24 of 2017, specifically focusing on the criteria and procedures for drug registration. This amendment reflects a response to t...

TFDA Requirements for Summary Product Characteristic (SPC) Thailand, governed by the Drug Act B.E.2510. The key points are as follows 1. Legal Basis and Scope Article 79 of the Drug Act mandates that no drug can be manufactured or imported into Thailand without obtaining marketing authorization from the Thai Food and Drug Administration (TFDA).  Articles 80, 81, and 82 of the Drug Act specify the application dossier requirements, including quality, non-clinical, and clinical infor...