ChemLinked BaiPharm Portal has been delivering and decoding China's pharmaceutical regulations to help international drug makers access the Chinese market. Here are the 10 regulatory topics that our readers are most concerned about in 2021.
Top Five News
ChemLinked BaiPharm News delivers new pharmaceutical regulations and market updates in China.
China started to implement its Good Pharmacovigilance Practices (GVP) on Dec. 1, 2021. The GVP applies to pharmacovigilance activities, which monitor, identify, evaluate and control adverse drug reactions (ADRs) and other medication-related negative reactions.
The Chinese GVP underlines that MAHs should assume the legal obligation even if pharmacovigilance affairs are entrusted to a third party.
2. China Waives Tariffs for Importing OTC Drugs via a Pilot E-commerce Program
In May 2021, China's State Council granted a pilot program for retailing imported drugs in Henan Province through cross-border e-commerce. The program sets the tentative tariff rate at zero for 13 over-the-counter (OTC) drugs approved by China NMPA.
The pilot program operates in a mechanism through which hospitals, pharmacies, and patients can directly purchase overseas drugs. [Catalog of OTC Drugs in China]
Mechanism for Retailing Imported Drugs in Henan Province via the Cross-Border E-commerce Pilot Program
3. China Cracks Down on Monopolies in Active Pharmaceutical Ingredient Industry
In Nov. 2021, China issued the Anti-Monopoly Guidance for Active Pharmaceutical Ingredients (APIs) against monopoly agreements, abuse of market power, and concentration of undertakings that eliminates or excludes competition.
Given last year's cases that API monopolies even appeared in small companies, the Guidance particularly asks small-sized API suppliers to report to the authority before engaging in a concentration of undertakings.
4. China to Carry Out Insulin VBP (Volume-based Procurement)
On Nov. 30, 2021, China revealed the final result of the insulin procurement tender. 11 companies, including Novo Nordisk, Gan & Lee, and Eli Lilly, won the bid to provide a total of over 212 million insulin doses to Chinese hospitals.
It was the first time China had expanded the volume-based procurement (VBP) program to biological products from chemical drugs. The nationwide VBP program, featuring sharp price cuts and bulk purchasing, has been held for six rounds in China.
5. China Implements New Medical Device Registration and Filing Rules
In Oct 2021, China's Administrative Measures for Medical Device Registration and Filing came into force. The Measures covers medical device classification, registration and filing documentation, conditions for exempting clinical evaluation, etc.
Besides the registration and filing measures, Regulations for the Supervision and Administration of Medical Devices and the medical device master file system, both taking effect last year, also play significant roles in regulating the medical device industry.
Top Five Insights
ChemLinked BaiPharm Insights are in-depth analysis of China's major pharmaceutical regulations and policies.
1. China DMF Filing for Active Pharmaceutical Ingredients, Excipients and Packaging Materials (AEPs)
The insight specifies the regulatory requirements for DMF filing:
DMF filing scope;
Documentation requirements;
Filing procedures;
Administration fees;
Post-filing annual reports, etc.
Thanks to the DMF filing system, AEPs can access the market faster. AEPs suppliers can usually complete DMF filing within 4 to 6 months, then immediately provide on-file AEPs to drug product companies. [Relevant Webinar]
2. Expedited Programs for Drug Registration in China
The insight provides detailed graphics on procedures for expediting marketing authorization through four programs:
breakthrough therapy designation (BTD);
conditional approval (CA);
priority review (PR);
special approval (SA).
It will save applicants much time if the proposed drug product is qualified for joining one of the programs. For example, the technical review for new drug applications (NDAs) under the PR program is shortened to 130 workdays and 70 workdays for rare disease drugs.
3. Special Medical Zones as Market Entry Pathways to China
China allows designated special zones to adopt policies more open to international medicines and medical devices than before. Foreign drugs can enter the Boao Lecheng International Medical Tourism Pilot Zone in Hainan Province even without being approved by China's national-level drug regulator NMPA.
Another example is urgently needed drugs that already used in Hong Kong and Macau's public hospitals are permitted to enter designated medical institutions in the nine mainland cities of the Greater Bay Area.
4. China's Marketing Authorization Holder (MAH) System
The MAH system, implemented in 2019, brings pharmaceutical companies flexibility without compromising compliance. The flexibility lies in that a drug MAH no longer has to be the manufacturer. Manufacturing activities can be entrusted to contract manufacturing organizations (CMO).
Meanwhile, an MAH shall shoulder the primary responsibility for its approved drug throughout the product's whole life cycle. It shall also follow the MAH system's procedures for transferring the marketing authorization and entrusting the manufacture. [Relevant Webinar]
5. Comparing China and US Drug Patent Linkage Regulations
In July 2021, China released the Measures for Implementing the Early Resolution Mechanism for Drug Patent Disputes (Trial) with immediate effect.
The regulation is an effort to balance the patent protection of innovative drugs and the development of generics. MAHs of innovative drugs can protect their patents by bringing a lawsuit or filing for an administrative ruling to trigger a 9-month stay of the generic drug's application. First generics that successfully challenge the registered innovative drugs can enjoy 12-month market exclusivity.
After the implementation of the new Measures, China's drug patent regulations highly resemble the US Hatch-Waxman Act but still feature some details tailored to Chinese domestic conditions.
Thank you for reading us last year. In 2022, we will continue writing news & insights for our readers. Leave a message if you have any advice or comments. Your feedback would be greatly appreciated.
