China Life Sciences & Healthcare Monthly Update – September 2018

NHC guidelines on the clinical application of new anti-tumour drugs, 21 September

The National Health Commission (“NHC”) of the People’s Republic of China (“PRC”) released the Guidelines on the Clinical Application of New Anti-tumour Drugs (“Guidelines”) on 21 September 2018. New Anti-tumour drugs refer to small-molecule targeted medicines and large-molecule monoclonal antibody medicines under the Guidelines.

The Guidelines are divided into two parts. The first part introduces some general principles on anti-tumour drugs. For instance, preconditions of the application of the anti-tumour drugs include: the diagnosis of the malignant tumour being confirmed through histopathology and anti-tumour drugs with specific targets must pass the genetic testing. The second part introduces 42 types of anti-tumour drugs and their application principles.

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

State Council adjusts the national essential medicine system, 19 September

The State Council of the PRC released the General Opinions on Adjusting the Essential Medicine System (“Opinions”) on 19 September 2018.

Compared to the current system for essential medicines, the main changes include:

• The National Essential Medicine List should be updated regularly (about every three years). The authority will add or remove medicines based on the efficacy, safety, cost-effectiveness, adverse drug reaction and other relevant criteria.
• The manufacturer should be primarily responsible for the supply of its essential medicines. In the event of medicine shortages caused by the manufacturer, it should assume liabilities for breach of contract. In addition, the authority will list that manufacturer onto the dishonesty record.
• The punishment for the abuse of a dominant position and monopoly agreements in the market of essential medicines will be more severe.
• For generic drugs, the authority will prioritise the review of applications relating to the addition of new medicines that have passed the Quality and Efficacy Evaluation1.

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

China issues regulations on digital healthcare, 14 September

Two authorities, the NHC and the State Administration of Traditional Chinese Medicine of the PRC, released three regulations for remote healthcare on 14 September 2018. Remote healthcare refers to health services (e.g. diagnosis) conducted remotely (e.g. via an Internet hospital).

1. The Administrative Measures for Internet Diagnosis (Trial for Implementation) (“Measure 1”) Under Measure 1, Internet Diagnosis refers to medical institutions that, together with their registered doctors, use the Internet or other information technology (“IT”) to operate referrals of common and chronic diseases and the engagement service of the “Internet +”2 family doctors. Only medical institutions having practice licences can provide Internet Diagnosis services. In addition, medical institutions shall not use Internet Diagnosis on a patient’s first visit. Doctors are allowed to write a prescription for some of the common and chronic diseases online. The online prescription should be signed by the doctor with the electronic signature. In addition, the online prescription must be reviewed by a pharmacist. Following the pharmacists’ review, the medical institution and the medicine manufacturer can entrust a qualified third party to deliver the medicine on the prescription.
2. The Administrative Measures for Internet Hospitals (Trial for Implementation) (“Measure 2”) Under Measure 2, Internet Hospitals refer to fictitious hospitals operated by and based on real hospitals or medical institutions. The establishment of an Internet Hospital must be approved by the authority. If a real hospital independently applies to establish an Internet Hospital, that Internet Hospital must share the same name with the real hospital. It is also the real hospital that would assume all the legal liabilities of its Internet Hospital. If a real hospital jointly applied to establish an Internet Hospital with a third party, the name of the Internet Hospital should consist of the both parties’ names. All parties should assume legal liabilities in accordance with their cooperation agreement.
3. The Administrative Measures for Remote Healthcare Services (Trial for Implementation) (“Measure 3”)

Under Measure 3, remote healthcare services refers to:

• hospital A inviting hospital B to provide remote healthcare services for a patient of hospital A via the Internet or other technologies; and

• hospital A or a third party establishing a remote healthcare service platform, where other hospitals can register and provide remote healthcare services to hospital A’s patients. In this case, all the parties should agree on the allocation of liabilities.

There are some common provisions shared between the three Measures. For example, a medical institution can cooperate with a third party to provide Internet Diagnosis, and to operate Internet Hospitals or remote healthcare service platforms; all parties must comply with the relevant data security and privacy protection regulations.

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

Clarification of the role of China National Medical Products Administration, 11 September

The State Council of the PRC released a document on 11 September 2018, clarifying the role of the recently restructured National Medical Products Administration (“NMPA”) which is formerly named China National Drug Administration. NMPA will be responsible for:

• the supervision of quality and safety regarding medicines, medical devices and cosmetics;
• drafting regulations and national standards for medicines, medical devices and cosmetics;
• the registration of medicines, medical devices and cosmetics;
• the post-marketing risk control of medicines, medical devices and cosmetics; and
• the registration of licenced pharmacists, etc.

Some departments of the State Council of PRC have been reorganised since March 2018 (see our previous Law-Now article here). The responsibilities of China Food and Drug Administration (“CFDA”) are split into two new departments: the State Administration for Market Supervision will take the responsibilities related to food administration; other responsibilities will be transferred to NMPA.

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

NMPA solicitation on the ADR reporting system, 7 September

NMPA released the Guidelines on the Collection and Reporting of Individual Adverse Drug Reactions (Draft for Comment) (“Draft”) on 7 September 2018. It is open for public comment until 20 September 2018.

According to the Draft, the individual Adverse Drug Reaction (“ADR”) refers to the adverse drug reaction suffered by an individual patient who takes the drug. Reports on the individual ADR refer to an individual ADR report which has been filled in by a Market Authorisation Holder3 (“MAH”) in accordance with the requirements of the authority.

1. The collection of the individual ADR information The MAH has the legal obligation to collect the individual ADR information from doctors, pharmacists, medicine retailers, complaining calls, academic publications, the Internet and other sources.
2. The response to the individual ADR The MAH should objectively, truthfully and accurately record the individual ADR information. To make a valid report, the MAH must record four necessary elements: the identifiable patient, the identifiable reporter, the problematic drug and the adverse drug reactions. The MAH should confirm the aforementioned information and report it to the authority.
3. The analysis of the individual ADR The authority will analyse the received report. If the ADR is different from the descriptions of the drug instruction, it will be defined as a new adverse drug reaction. If the ADR causes death, threatens lives or causes other severe medical accidents, it will be defined as a severe adverse drug reaction. In addition, the authority will analyse the causation between the problematic drug and the patient’s reaction in accordance with the guidelines of the World Health Organisation.
4. The reporting of the individual ADR The individual ADR report should be submitted through the specific supervising system designated by the authority. The report must be submitted within the designated time period. If the MAN submits the report outside China, the time period will starts from the time that it knows such individual ADR information.
5. The follow-up investigation If the individual ADR information first received is not complete, the MAH should make further investigation by mail, email, telephone or other approaches. For those ADRs causing death, the MAH must conduct an investigation on the conditions of the patient, the use of drugs, the occurrence of adverse drug reactions, diagnosis and treatments, etc.
6. Data management The MAH should keep all of the data (including the original ADR recording, follow-up investigation, etc. no matter it is in the electronic or hardcopy format) true, complete, secure, confidential and traceable during the whole life-circle of the medicine.

Although the Draft has not taken effect yet, it indicates the possible upcoming changes on the ADR regulatory regime.

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

1 The Quality and Efficacy Evaluation is an evaluation to analyse the consistent quality and efficacy of generic drugs. (See the Opinions of the General Office of the State Council on Conducting the Consistency Evaluation of the Quality and Efficacy of Generic Drugs)
2 “Internet Plus” is purposed by the PRC Prime Minister Li Keqiang. It refers to the application of the Internet and other information technology in conventional industries. For example, “Internet + Healthcare” means using Internet technology like artificial intelligence to solve the problems in the public health industry. (See the Guiding Opinions of the State Council on Actively Propelling the Internet Plus Action Plan)
3 A Marketing Authorisation Holder (MAH) is a company, firm or non-profit organisation that has been granted a marketing authorisation. The marketing authorisation allows the holder to market a specific medicinal product in specific countries.