The Pharma Legal Handbook: Asia Growth & Transition Market
The Pharma Legal Handbook: Baltics
Articles
Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The Ministry of Health (MOH) is the primary body responsible for public health in Saudi Arabia. It sets national health policies, issues licenses to healthcare providers (public and private), oversees public hospitals and primary…
A brief overview of the situation regarding traditional medicines and OTC products in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?…
In addition to the clinical data obtained through clinical studies please list the data required for a. Market approval In addition to clinical trial data, the following documents are required for market authorization in Saudi Arabia: Quality/CMC Module: Includes full GMP certificates (PIC/S or WHO type) and a local QP release plan. Non-clinical studies:…
Romania Mușat & Asociații June 2019
Marketing, Manufacturing, Packaging & Labeling, Advertising: Romania
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? In order to be placed on the Romanian market, a medicinal product needs a marketing authorization, which can be issued by NAMMD at local level (under the national evaluation procedure or under the…
Panama AFRA June 2019
Product Liability: Panama
The legal framework for product liability in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99. 1. What types of liability are recognized in your jurisdiction? Contractual and extracontractual responsibility. These can be administrative, civil, or criminal…
Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoids are substances subject to national control for therapeutic, medical, veterinary, scientific and research use. 2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? The regulatory authorities are the Pharmaceutical and Drug Department from the Ministry of Health and the Ministry of…
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Authority that regulates drugs, biologicals and medical devices in Panama is the Ministry of Health through the following authorities: Pharmaceutical and Drug Department Medical Devices National Department Bioethical National Committee. See the Chapter: Directory of…
Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The primary HTA authority is the Saudi Food and Drug Authority (SFDA), which hosts a dedicated HTA/Economic Evaluation Unit established in 2023. Its main responsibility is to evaluate clinical and economic evidence (EES) for: New chemical entities Biologics Re-pricing of…
Saudi Arabia Youssry Saleh Law Firm June 2019
Expenditure Control and Cost-Containment Policies: Saudi Arabia
Please describe the main cost containment policies in place in your country and their fundamental principles a. Pricing and impact of generic/biosimilar approval The SFDA applies automatic price reductions for generics and biosimilars: The 1st generic is priced ≥35% lower than the originator. The 2nd generic is ≥55% lower. Additional generics must be ≥10%…
Saudi Arabia Youssry Saleh Law Firm June 2019
Post Market-Approval Processes and Regulations: Saudi Arabia
What are the pricing models, processes and principles for originator drugs? Originator drugs (innovator medicines) are priced by the Saudi Food and Drug Authority (SFDA) following the principles outlined in its 2023 Drug Pricing Guidelines. The pricing process includes: External Reference Pricing (ERP): SFDA compares prices with a reference basket of 34 countries. Internal Reference…
