The Pharma Legal Handbook: Asia Growth & Transition Market
Articles
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…
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:…
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,…
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%…
China Fangda Partners January 2019
Product Liability: China
1. What types of liability are recognized in your jurisdiction? Violation of laws and regulations may result in civil liabilities, administrative penalties and criminal liabilities. Civil liability can include: (1) Desistance from infringement; (2) Removal of obstacles; (3) Elimination of dangers; (4) Return of property; (5) Restoration to status quo ante; (6) Repair, reworking or…
Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Yes. The SFDA published the Economic Evaluation Studies Guideline (PDF, July 10, 2024), which outlines comprehensive methods and includes a checklist. Followed by the Pharmacoeconomic Submission Portal Manual (January 2025), detailing dossier preparation and submission protocols. Have local Authorities published…
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
Patents & Trademarks: China
1. What are the basic requirements to obtain patent and trademark protection? Please refer to Question 3 below. 2. What agencies or bodies regulate patents and trademarks? In China, patents are regulated by the China National Intellectual Property Administration (“CNIPA”) and trademarks are regulated by the China Trademark Office (“CTMO”). The PRC Patent Law…
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…
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…
