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,…
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…
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…
China Fangda Partners January 2019
Orphan Drugs & Rare Diseases: China
1. What is the definition of Rare Diseases in your country? As of now, there is no definition of Rare Diseases in China. The List of Rare Diseases (罕见病目录) promulgated by the National Health Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the NMPA and the Bureau of Traditional…
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…
1.Please make a general introduction to the public health sector in your country and its organization Saudi Arabia provides universal health coverage primarily funded by the government through a tax-based model. The healthcare system is organized in a tiered structure led by the Ministry of Health (MOH), which operates: • Over 287 public hospitals •…
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:…
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…
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…
China Fangda Partners January 2019
Regulatory Reforms: China
1. Are there proposals for reform or significant change to the healthcare system? “One-Invoice” Policy The “one-invoice” policy in the drug distribution has taken place on a trial and non-compulsory basis in a few regions in China. While the “two-invoice” policy which was initially launched nationwide in 2016 requires that the issuing of the drug…
