China Life Sciences & Healthcare Monthly Update - April/May 2019

China

NMPA releases draft provisions of on-the-spot inspections for drug registration: 17 May 2019

The National Medical Products Administration ("NMPA") of the People's Republic of China ("PRC") released the draft for the Administrative Provisions on On-the-spot Inspection for Drug Registration (Draft for comment) ("Draft") on 17 May 2019. The Draft will be open for public consultation until 3 June 2019. In the Draft, on-the-spot inspection refers to on-site inspection for pre-clinical research, clinical trials and the process of mass production for drug registration applications. The purpose of an on-the-spot inspection is to ensure that the process of development and manufacturing as described in the application is true, accurate and complete, and that all data is traceable.

According to the Draft, the national drug examination institution under the NMPA has the discretion to inspect samples or to extend the scope of an inspection to include production sites, suppliers and any other contractual entities related to the Active Pharmaceutical Ingredients, excipients and package materials of the drug in question. All entities and individuals associated with a drug have an obligation to assist and to provide all necessary records, data, information and materials. The inspection team will conduct an on-the-spot inspection and then submit a report for review by the national drug examination institution, which will issue a conclusion based on the composition of a product and any risks it poses.

To read the full text of the Draft (in Chinese only), please click here.

NPC releases draft amendment to the Drug Administration Law: 26 April 2019

The Standing Committee of the National People's Congress ("NPC") of the PRC released the Amendment to the Drug Administration Law ("Draft Amendment") on 26 April 2019. The Draft Amendment was open to public consultation until 25 May 2019.

The Draft Amendment has twelve chapters: general provisions, drug development and registration, Market Authorisation Holder ("MAH"), drug manufacturing, drug distribution, pharmacy management for medical institutions, post-market drug management, drug price and advertising, drug storage and supply, supervision and management, legal liabilities and miscellaneous provisions.

The Draft Amendment introduces a national MAH regime and clarifies the MAH's responsibilities during the life cycle of a drug, including the MAH's responsibility for non-clinical research, clinical trials, manufacturing and distribution, post-market research and Adverse Drug Reaction ("ADR") supervision. The MAH should establish a drug quality control system, and should ensure that contractors (for manufacturing, distribution, storage or transportation) exercise quality control and risk-management capacity. Subject to approval, the MAH is permitted to authorise another entity to market its drug product. If the MAH is an overseas enterprise, its representative office or the designated enterprise in China should perform the MAH's obligations and jointly assume its liabilities.

Regarding Internet pharmacies, the Draft Amendment requests that an online platform file with the authority and perform obligations such as a qualification examination and, if necessary, illegal-act reporting. In addition, the Draft Amendment stipulates that no prescription drugs can be distributed via the Internet.

To read the full text of the Draft Amendment (in Chinese only), please click here.

NPC releases the second draft vaccine management law: 26 April 2019

The Standing Committee of the NPC released the second draft of the PRC Vaccine Management Law ("Second Draft") on 26 April 2019. The Second Draft was open for public consultation until 25 May 2019. The most important changes from the first draft are summarised below.

In order to encourage vaccine development and innovation, urgently needed vaccines can enjoy priority review and be exempt from lot release approval. In terms of lot release applications for imported vaccines, an applicant should provide the authority with the certificate of origin, the lot release certificate, the drug registration certificate, lot manufacturing and examination records and samples. If a relevant vaccine is exempt from lot releases in the country of origin, the relevant certificate will prove that such a release is required.

According to the Second Draft, when death, disability or organ damage occurs following vaccination, compensation is necessary as long as the possibility cannot be excluded of a post-vaccination adverse reaction. If the MAH or the vaccination agency is aware of any defects in the vaccines, but still conducts distribution or vaccination, causing death or serious damage, the recipients or their relatives are entitled to obtain punitive damages.

To read the full text of the Second Draft (in Chinese only), please click here.

NMPA releases draft circular on drug-device combination products: 17 April 2019

The NMPA released the Circular on Matters Concerning Adjusting the Determination of Attributes of Drug-device Combination Products (Draft for comment) ("Draft Circular") on 17 April 2019. The Draft Circular was open to public consultation until 17 May 2019. Under PRC law, combination products made up of a drug and a medical device must be registered as either a pharmaceutical or a medical device.

According to the Draft Circular, an applicant for a combination product should file an online application on the official website of the National Institutes for Food and Drug Control (http://www.nifdc.org.cn/nifdc/). Among other things, the applicant should provide literature reviews and supporting materials regarding the combination product's primary mode of action, and clarify the pharmaceutical components of the combination products. If there have been any similar or relevant products marketed in China or any foreign country, the applicant should introduce the structure, components, intended purpose, management category and supporting materials of these products. Concerning an application for a foreign product, the applicant should provide certificates demonstrating that the combination product has been marketed in a foreign country. After reviewing these materials, the authority will announce whether the product is to be registered as a drug or a medical device.

To read the full text of the Draft Circular, please click here.

NHSA adjusts the National Catalogue of Drugs under medical insurance: 17 April 2019

The National Healthcare Security Administration ("NHSA") released the 2019 Work Plan for Adjustments to the Catalogue of Drugs Covered by the National Medical Insurance (including work-related injury insurance) ("Plan") on 17 April 2019.

According to the Plan, drugs that have been approved by the NMPA for marketing before 31 December 2018 may be included in the Catalogue of Drugs (including work-related injury insurance) ("Catalogue"). The NHSA will give priority to the following products: national essential medicines, anti-cancer drugs, orphan drugs, medicines for chronic diseases, medicines for children and medicines for first aid.

Medicines can be included into the Catalogue by regular means or negotiation. Medicine varieties whose prices are equivalent to or lower than existing varieties can be included in the Catalogue by regular means if they meet the relevant efficacy and safety requirements. Patented medicines that have a greater impact on insurance funds or have higher prices can be included into the Catalogue only after negotiation. The NHSA will organise an expert group to negotiate with pharmaceutical companies.

The following is the timetable of the adjustment to the Catalogue.

Phase

Progress

Preparation (January to March)

The NHSA-organised expert groups review the database together with other authorities.

Review (April to July)

Soliciting the medicine's demand under medical insurance, determining the candidate list, selecting experts, determining the list of included and excluded drugs, and seeking opinions from relevant companies on the negotiated drug list.

 

Issuance of the regular Catalogue (July)

The NHSA publishes the new varieties included by regular means and the medicine list subject to negotiation.

 

Negotiation (August to September)

The NHSA negotiates with pharmaceutical companies on the payment standard under the national medical insurance system.

 

Issuance of the negotiation result (September to October)

The NHSA publishes the new varieties included through negotiation.

To read the full text of the Plan (in Chinese only), please click here.