ChemLinked BaiPharm Portal has been tracking and interpreting China’s pharmaceutical regulations during the year of 2022. Here are the top 10 stories we selected for you to grasp China’s regulatory dynamics.
Top Five News
ChemLinked BaiPharm News delivers the latest pharmaceutical regulations and market updates in China.
1. China Specifies Key Points for Pharmacovigilance Inspections
On April 15, 2022, China National Medical Products Administration (NMPA) issued the Pharmacovigilance Inspection Guidelines (hereafter referred to as the Guidelines) with immediate effect. The Guidelines lists key points for national and provincial-level medical products administrations to carry out pharmacovigilance inspections.
The administrations will pay attention to the following items subjected to pharmacovigilance inspections:
1) Drug safety committee (e.g., whether the MAH has established such a committee; whether the committee has clear and reasonable responsibilities);
2) Pharmacovigilance department (e.g., whether the MAH has launched such a special department);
3) Relevant departments (whether the MAH has assigned pharmacovigilance responsibilities to other departments), etc.
2. China Releases MedDRA Coding Guidance for ADR Reports
On May 6, 2022, China NMPA released the MedDRA Coding Guidance for Drug Marketing Authorization Holders (MAHs) (hereafter referred to as the Guidance). MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical terminology covering registration, documentation, and safety monitoring of medical products.
The Guidance is for MAHs to use MedDRA coded terms in post-marketing adverse reaction reports. The reports include the initial reports collected by the MAH itself and from the National ADR Monitoring System. Data in the initial reports, if described by non-standard terms, should first be standardized into "verbatim terms" and then coded into the appropriate lowest level terms (LLT) according to MedDRA Term Selection: Points to Consider. The data subject to standardization covers disease, adverse reaction terms, and examination items.
3. China Permits Online Sales of Prescription Drugs Nationwide
On December 1, 2022, China's Administrative Measures for Supervising Online Sales of Drugs (hereafter referred to as the Measures) took effect, allowing the online sales of prescription drugs nationwide after regional pilot programs in Hainan and Shenzhen.
To ensure safety for selling drugs online, the Measures specifies regulatory requirements for online sellers and third-party online platforms. Also for safety concern, China NMPA bans a list of drugs from online sales, including vaccines, blood products, anesthetics, psychiatric drugs, etc.
4. China Includes 327 Products into the 7th National VBP
On July 18, 2022, China National Joint Drug Procurement Office announced the list of 327 products for the 7th national volume-based procurement (VBP). The 327 products are owned by 217 companies that won the bid to be VBP suppliers. Among the companies, six are overseas companies—Hetero Labs, Bracco Sine, Almirall, Sandoz, and Pfizer.
Drug Product | Company | Specification | VBP Price |
Oseltamivir Phosphate Capsules | Hetero Labs Limited | 75mg*10 capsules per blister pack in each box | 16.50 yuan/box |
Iopamidol Injection | Shanghai Bracco Sine Pharmaceutical Industry Co., Ltd. | 100ml: 37g(I)*10 bottles in each box | 1,192.79 yuan/box |
Ebastine Tablets | Almirall, S.A. (entrusted manufacturer: Industrias Farmaceuticas Almirall, S.A.) | 10mg*10 tablets per blister pack in each box | 3.49 yuan/box |
Ezetimibe Tablets | Sandoz Inc. (entrusted manufacturer: Lek Pharmaceuticals d.d.) | 10mg*30 tablets in each box | 38.89 yuan/box |
Micafungin Sodium for Injection | Astellas Pharma Europe B.V. (entrusted manufacturer: Astellas Pharma Tech Co., Ltd. Takaoka Plant) | 50mg*1 bottle in each box | 86.81 yuan/box |
Tigecycline for Injection | Pfizer Europe MA EEIG (entrusted manufacturer: Wyeth Lederle S.r.l.) | 50mg*10 phials in each box | 415.90 yuan/box |
5. China Consults on the Regulations for Implementing the Drug Administration Law
On May 9, 2022, China NMPA released the draft of the revised Regulations for Implementation of the Drug Administration Law (hereafter referred to as the Regulations) for public comments.
The Regulations was first issued with immediate effect in 2002, and was later revised in 2019. Compared to the 2019 version, the 2022 version includes 101 more articles to conform to the pharmaceutical policy reforms in the recent years and the Drug Administration Law revised in 2019. The new contents involve marketing authorization holder system, patent protection, and pharmacovigilance.
Top Five Insights
ChemLinked BaiPharm Insights are in-depth interpretation of China's major pharmaceutical regulations and policies.
1. FAQ on Rare Disease Drugs (Orphan Drugs) in China
In recent years, rare disease drugs have been receiving more attention from Chinese authorities. The government has enacted a series of policies for improving the availability of rare disease drugs, including releasing the Catalog of Rare Diseases, expediting the review of rare disease drugs, and adding more rare disease drugs to the National Reimbursement Drug List (NRDL).
The article answers the frequently asked questions:
1) How does China define a rare disease drug?
2) Does China accept foreign clinical trial data?
3) Are there any preferential policies for expediting the approval of rare disease drugs?
4) What are the procedures for a rare disease drug to be approved in China?
5) How many rare disease drugs have been approved in China?
6) What rare diseases still have no effective treatments in China?
7) Does China have any pricing & reimbursement policies for rare disease drugs?
2. Decoding China's Good Pharmacovigilance Practices (GVP)
Chinese GVP took effect on December 1, 2021. It applies to pharmacovigilance activities of MAHs and drug registration applicants approved to carry out clinical trials in China.
In pharmacovigilance activities, MAHs or applicants monitor, identify, evaluate, and control ADRs and/or other negative reactions related to medication.
The GVP covers regulations in the following aspects:
1) quality management;
2) personnel and resources of the organization;
3) monitoring and report;
4) risk identification and assessment;
5) risk control;
6) management of documents, records, and data;
7) pharmacovigilance during clinical trial.
3. How to Get China's Marketing Authorization for OTC Drugs
In China, the marketed drugs are divided into prescription drugs (Rx drugs) and non-prescription drugs. Non-prescription drugs, also known as over-the-counter (OTC) drugs, can be bought and used without prescription from a licensed physician.
Currently, there are two routes for getting OTC drug marketing authorization from China NMPA:
1) Unmarketed OTC drug applying for marketing authorization under the drug classification rules, which are the same for prescription drugs.
2) Marketed prescription drug applying for Rx-to-OTC switch.
4. How to Sell OTC Drugs to China via Cross-Border E-Commerce
To market OTC drugs in China, companies used to obey the same documentation requirements and marketing authorization application procedures as prescription drugs.
In recent years, cross-border e-commerce (CBEC) has been developing as a different approach to enter China's OTC drug market. CBEC here means selling goods on a Chinese third-party online CBEC platform from overseas to individual consumers in China.
Compared to general trade that requires 2-5 years for marketing authorization application, CBEC is faster—only 2-3 months, mainly spent on appointing a Chinese agency, filing records at Chinese customs, choosing Chinese CBEC platforms to set up online stores, etc.
5. Comparing First Generic Drugs in China and the US
Generics are usually more affordable than original drugs, yet are required to be equivalent in quality and effectiveness. To create moderate competition and increase the availability of medicines, both China and the United States give incentives to the first generic drug that has successfully challenged the patent of the brand-name drug.
The patent linkage systems in China and the US both feature patent statement by the generic drug applicant, stay period for the generic drug application in patent dispute, and market exclusivity for the first generic drug that successfully challenges the brand-name drug.
But in detail, the definition, registration process, the starting date and the lengthy of market exclusivity, and some other regulatory requirements differ in China and the US.
Thank you for reading our articles last year. In 2023, we will continue providing China’s pharmaceutical updates. We would really appreciate it if you leave your advice or comments at our contact box.
