China grants market exclusivity to pediatric and orphan drugs via new drug rules
Elise Mak ·05/23/2022

China’s drug regulators are accelerating the development pathway of pediatric and orphan drugs through revised regulations. Biotech companies that focus on developing these drugs will be rewarded with market exclusivity.

A revised draft of the Implementation Regulations on the Drug Administration Law released on May 9 shines a light on the NMPA’s intention to align with international standards, encourage drug innovation, improve clinical trial management and protect intellectual property rights.

This marks the first overhaul of the regulations since September 2002, which adds 95 new articles to the 86 already in effect.

Articles 28 and 29 set an exclusivity period of up to 12 months and seven years for new pediatric and orphan drugs respectively, meaning that no competitor drugs will be approved for marketing during the period.

The marketing applications of drugs in these two categories will be granted priority review to encourage R&D. Companies are advised to communicate closely with regulators during R&D and registration to speed up the process. They are also encouraged to expand the indications of the marketed drugs.

Chang Jianqing, Vice President of Drug Regulatory Policy at Tigermed, confirmed that encouraging the development of pediatric drugs has been a focus for drug regulators, who have made it clear the key role that drugmakers play in addressing the unmet needs of the country.

“The draft includes a lot of measures that are about the R&D of pediatric drugs, which shows attention for pediatric patients and incentivises companies that undertake R&D,” she wrote in a recent op-ed at PharmaDJ.

The incentives for biotech companies are in line with the NMPA’s consistent policy to encourage clinical value-oriented drug innovation, which is captured in Articles 9 and 10. Chang said the draft further specifies how regulators encourage this every step of the way, from IND preparation to marketing approval.

Article 9 stipulates that to encourage innovation, China will improve its drug innovation system, support basic research, applied research and original innovation of drugs, promote clinical value-oriented drug innovation, and support companies to use advanced technology and equipment to improve drug safety.

It further states that China will provide support for science and technology projects, financing, credit, bidding and procurement, drug pricing and health insurance. The country will also support companies to set up or jointly set up R&D institutions, encourage them to cooperate with researchers, strengthen the protection of intellectual property rights of drugs, and enhance the capability to undertake drug innovation independently.

To launch new drugs faster, Article 10 makes clear that the NMPA puts in place breakthrough therapy designations, conditional approval for marketing, priority review and approval, and a special approval system to encourage drug innovation and shorten the time needed for developing and reviewing drugs. It is on the NMPA to then clarify the scope, procedures, supporting policies, and other requirements.

Acceptance of overseas data is also written into law this time. Article 23 states that if the applicant's clinical trial data are obtained outside China and meet the requirements of the NMPA, the data can be used in marketing applications. If data generated from international multi-center drug clinical trials in China by foreign drugmakers meet the requirements, they can also be used to support marketing applications.

As China continues to be a member of the ICH, Article 8 requires regulators to formulate technical requirements and guidelines for the R&D, review and inspection of drugs by taking references from international technical standards for pharmacokinetic studies, non-clinical research and clinical trials.

“The draft marks the first time that China specifies it will take reference from international practices and writes it into law to strengthen alignment with international standards. This is of utmost significance to innovative drugmakers that aim to go global,” Chang commented.

She added that as of February 2022, China has implemented 53 ICH guidelines and laid down a clear timetable for implementing seven more. China joined the ICH as its eighth regulatory member in June 2017 and continued to hold on to the membership in June 2021.

The draft also touches on the patent linkage system, which has just been implemented in China since July 2021, to lay out what the NMPA might do should disputes arise.

According to Article 38, when disputes take place during the marketing application, drug regulators shall keep on reviewing the application. For chemical drugs that have passed technical review, the NMPA shall decide whether to grant marketing approval according to the court’s ruling. If a ruling has not been handed down in time, the NMPA shall approve the drug to come to market.  

Another piece of good news for drugmakers is China’s pledge to protect data.

Under Article 40, China shall protect the undisclosed test data and other data of marketed drugs. Anyone other than the marketing authorization holder (MAH) should not use the undisclosed test data and other data for improper commercial use.

The Article further specifies that within six years from the date of the marketing authorization, the NMPA shall not approve drugs by other applicants who use the data to support their marketing application without the MAH’s consent, unless they generate such data on their own.

Unless it is of public interest or measures have been taken to keep the data from improper commercial use, the NMPA shall not disclose these data.

“As patent linkage system and data protection are written into the draft, regulators have demonstrated their emphasis on protecting the intellectual property rights of drugs. This is a major improvement that concerns R&D-based biotech companies,” Chang said. 

Keywords: China grants market new drug rules orphan drugs
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