The Pharma Legal Handbook: Asia Growth & Transition Market
Articles
What are the pricing models, processes and principles for originator drugs? Drugs are provided by a medical institution or pharmacy to a patient based on the NHI Drug Price (a patient pays 10%, 20% or 30% (depending on age and other conditions) of the NHI Drug Price). As detailed in Question I. 2. a. above,…
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Several governmental agencies are responsible for the administration of drugs (including Chinese medicine, chemical medicine and biological products) and medical devices, including the following key players: • The National Medical Product Administration (“NMPA”), formerly known as the China…
CANNABINOID DRUGS 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs are not authorized in China. 2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? N/A 3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs? N/A 4. Which are the cannabinoid drugs…
China Fangda Partners January 2019
Marketing, Manufacturing, Packaging & Labeling, Advertising: China
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Please refer to Questions 3 & 6 of the Regulatory, Pricing and Reimbursement article regarding the authorization of drugs and medical products. 2. What is the authorization process for the marketing of generic versions…
Are there any Managed entry agreements in place in your country? (If so, please list them) Yes, Saudi Arabia has implemented two types of Managed Entry Agreements (MEAs) under the Ministry of Health’s “Managed-Entry Agreement Policy” issued in January 2021. These include: A. Finance-based Price/Volume Agreement 1. Fundamentals & rationale The Marketing Authorization Holder (MAH)…
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
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…
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%…
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional Chinese Medicine (“TCM”) is a system for diagnosis, prevention and treatment that has existed for thousands of years and is regulated by the Regulations on Protection of Varieties of TCM and other relevant regulations. The regulatory requirements for…
China Fangda Partners January 2019
Localization: China
1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Yes. The key regulations are the Pharmaceutical Administration Law (药品管理法) and the Regulations for the Implementation of the Drug Administration Law (药品管理法实施条例). There are several announcements or decisions regarding the…
