Coronavirus: emergency processes aid China's response

Out-Law Analysis | 30 Apr 2020 | 9:52 am | 12 min. read

An emergency approval process for medical devices helped China overcome a shortage of medical materials and rapidly ramp up testing for coronavirus when the virus was spreading throughout the country.

A similar emergency process for vaccines is likely to be important to China's efforts to rapidly immunise the Chinese population against coronavirus when a suitable vaccine for the disease is identified. It could be brought into effect as early as within the next few weeks.

The emergency approval process for medical devices

It commonly takes years for medical device manufacturers to obtain marketing approval for their devices, regardless of the country in which marketing authorisation is applied for. Yet, in China, as the outbreak of coronavirus spread beyond the province of Wuhan, where it was first discovered, authorities in the country were able to track its progress and keep tight controls on its further spread because of specially-designed Covid-19 test kits.

The Covid-19 test kits were able to be put rapidly put into use just a few short weeks after the outbreak began in large part because of the emergency approval process (EAP) for medical devices that is in place in China.

The EAP was established in 2009 by the then State Food and Drug Administration, now National Medical Products Administration (NMPA), through a circular notification.

According to the circular:

  • EAP will be launched when there is an outbreak (or threat of outbreak) of emergency public health event.
  • The NMPA will decide on the duration of the EAP – i.e. when to initiate and when to end the process – based on the situation of the emergency event.
  • After NMPA's decision to initiate the EAP, the local MPAs will be responsible for carrying out marketing approvals for the relevant medical devices under EAP.

During the outbreak of Covid-19 in China, EAP was launched for approving medical devices relating to the testing and treatment of this new disease. By 5 February 2020, two weeks after the Wuhan lockdown was first implemented, NMPA and local MPAs had already approved 72 applications for medical device registration under the EAP, including for test kits, face masks, and protection suits, among other devices.

The precise scope of the EAP is unclear. However, based on the provisions of the 2009 Circular, as well as recent news coverage and regulations issued by local MPA relating to Covid-19, we are of the opinion that the EAP is solely designed for medical devices needed on an urgent basis in response to public health events like Covid-19. It is very unlikely that the EAP would apply to medical devices not related to the response to such emergency events.

How quick is the EAP?

The EAP process is very short and simplified in comparison to the normal approval process for medical devices. This is one of the main reasons why this special procedure has to be limited to medical devices for which there are real urgent needs. 

The normal procedures

There are broadly four steps involved under the normal procedures for obtaining marketing approval for a medical device in China. The overall process can take years to complete.

 

Steps

Class I Medical Devices (Non-invasive medical devices)

Class II, III Medical Devices

(Invasive / dangerous / implanted medical devices)

Formulation of product technical specifications

Such specifications to be filed with the local NMPA

Such specifications to be approved by the local NMPA

Sample registration testing

Applicant to submit product self-testing report

Only when the sample product has qualified in the registration testing process, could the applicant then apply for initiating clinical trials.

Clinical trials

Not applicable

First, a technical review must be completed in 40 working days;

Second, the NMPA has to decide whether to approve the start of clinical trial within 20 working days upon the technical review;

Third, clinical trials commence upon NMPA approval.

Marketing approval

Filing is required. The entire timeline depends on how well the application materials are prepared, and in practice it may take about one month to complete the filing.

After the above steps have been completed, the NMPA or local MPA will review the application and conduct a technical review and evaluation of the medical device – an on-site visit is usually required – and then issue approval. In practice, completion of this step might take several months to years.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The EAP

Under the EAP, the approval procedures for medical devices, and in particular Class II and III devices, are largely shortened. Instead of months or years, the duration of the process can be measured in days and weeks. Unlike under the normal procedure, there is no requirement for device manufacturers to go through any clinical trials for Class II or III medical devices before they can obtain marketing approval for emergency need. 

 

Steps

Class I Medical Devices (Non-invasive medical devices)

Class II, III Medical Devices

(Invasive / dangerous / implanted medical devices)

Submit introduction materials and explanations of the medical devices for emergency approval to NMPA

The NMPA has to set up a special expert panel to review the medical device for emergency approval and to make a decision – i.e. whether to approve the product to go through EAP – within three days.

Registration Testing

For medical devices that have been approved to go through the EAP, the relevant medical device testing institute can arrange testing within 24 hours upon receiving the sample and issue the testing report in a timely manner

Duration Approval

Upon the acceptance of the application for medical device approval under EAP, the NMPA, or local MPA, must complete the technical review/evaluation and issue the approval within five days.

Class II Medical Device:

 

Upon the acceptance of the application for medical device approval under EAP, the NMPA, or local MPA, must complete the technical review/evaluation within five days; and upon the technical review, to issue the approval within three days.

 

Class III Medical Device:

 

Upon the acceptance of the application for medical device approval under EAP, NMPA (or local MPA) to complete the technical review/evaluation within 10 days; and upon the technical review, to issue the approval within three days.

 

 

Effective term of a registration certificate issued under the EAP

In a normal approval process, the registration certificate issued for a medical device has an effective term of five years. There is no clear legal guidance on the effective term of a certificate issued under the EAP, however.

According to registration certificates issued for Covid-19 test kits, those certificates are "only intended for emergency provision for the diagnosis of Covid-19 with an effective term of one year / six months". Further, under some local regulations, registration certificates issued for certain Class II products under EAP – also for the purpose of Covid-19 – shall expire after the full closure of the epidemic.

It therefore appears that the effective term of an EAP approval for medical device, as well as the renewability or period of renewal for those devices, depends on the opinions of the NMPA, in reviewing the relevant medical device product under EAP, and local policies. The term is usually below one year.

Clinical trials

The EAP does not require clinical trials to be carried out for devices before they are issued with marketing approval or a registration certificate under the scheme. However, it is clear from recent practice in respect of approvals issued for Covid-19 test kits, that NMPA requires that the registrant should continue clinical trials testing and related procedures after they have been authorised to start selling the registered product. The registrant will need to, at the time of renewing the certificate, submit the summary report of clinical application data according to the NMPA requirements. However, those requirements have not yet been made explicit in any issued regulation.

Renewal

There is no clear requirement under the EAP regulation as to when the renewal application should be submitted, but under the general policy such application must be submitted six months prior to the expiry of the registration. This represents a relatively short period to prepare the relevant clinical data.

If the certificate expires after 12 months and cannot be renewed, it is not clear as to whether device manufacturers can apply for an EAP again. Most likely it would need to go through the normal approval process.

Emergency process for vaccine approval

The PRC Vaccine Administration Law (VAL) was adopted on 29 June 2019, and came into effect on 1 December 2019 – the month in which the outbreak of Covid-19 in China started.

The VAL provides for an emergency process for vaccine approval similar to the EAP for medical devices. It applies:

  • In respect of any vaccine that is urgently required to cope with materially emergent public health events or other events determined by state health authority the National Sanitation and Health Committee, the NMPA is allowed to approve the registration of such vaccine with certain conditions;
  • In the case of urgent events, such as emergent public health events or other events that seriously endanger public health, upon the proposal made by the National Sanitation and Health Committee of urgent use of vaccine for epidemic precaution and control and the review and consent of the NMPA, the relevant vaccine can be used on an urgent basis within a certain scope and period.

There has not yet been any vaccine granted emergency marketing approval under these general guidelines. However, recent news reports suggest that later this month or next certain vaccine could be granted approval for clinical trial or even for emergency use. 

Combatting coronavirus

Both the EAP for medical devices and the emergency process for vaccine approval are designed to cope with major public health challenges, such as emergent public health events such as the Covid-19 pandemic. 

To-date, the EAP has been adopted in a large number of cases to enable a quick and full testing of virus carriers so as to slow the speed at which the virus spreads. It has also been used to address the shortage in medical materials supplies that has arisen in light of the volume of people infected by the virus and the pressure that has put on the health system. 

We expect that the fast track procedure for vaccine approval will play an important role too in the months ahead in allowing vaccination across a wide range of the population, which, as many public health experts internationally have noted, is the only way to wipe out the existing and potential threats posed by Covid-19 against humans.