In response to a rapid increase in applicants seeking to bring drug-device combination products to market in China, the country’s National Medical Products Administration (NMPA) recently released new draft guidelines. With demand for innovative products to prevent and treat disease growing, the NMPA prepared the draft guidelines with the objective of clarifying processes for applicants.
Companies are advised to determine the key component of their product before applying. If the product leans more toward drug, then the applicant should submit a pharmaceutical application; if it’s more device-based, then the application should be made through the medical device regulation. When there is a need for a joint review, the drug and device agencies will collaborate to manage the submission.
When they first consider a submission, therefore, companies need to spend time defining how the product is best categorized – and either engage a professional consulting company to assist with the process or organize time with the regulatory agency to get their help before filing.
Key requirements
The new guidelines cover several key criteria that applicants must include with their submission. This includes a list of requirements for the file format and the type of information that must be contained in the submission. Applicants must also ensure they have a very clear product description for the drug-device.
The submission should also include clear details about the product’s clinical advantage and how it affects safety. What is the interaction between the device and the drug product? What is the content of the drug and the dose selection? What are the chemical and physical properties of the product? Are animal tests required and what stability studies have been carried out?
While the guidelines provide a clearer roadmap, how the applicant should go about addressing test requirements and how the tests should be performed would require further clarity during the implementation phase. What parameters need to be met? Once the studies have been performed, what does the report need to include to demonstrate the product is compliant?
Tackling uncertainty
The latest guidelines are a draft for public comments, which can be submitted to NMPA via email or calls to the Center for Medical Device Evaluation during the consultation period. In addition, NMPA might also organize specific seminars to discuss concerns and ideas with key stakeholders in the industry. It is expected that more detailed guidance will be issued in the future, and, indeed, the Guidelines for Registration Review of Qualitative, Quantitative and In Vitro Release Studies of Combination Medical Devices was published recently. In addition to more technical guidelines for drug-device combination products, NMPA is expected to put in place more regulations for post-marketing management, and also provide more opportunities for the applicants to communicate with the authorities.
While the draft guidance still has gaps, the NMPA has advised applicants to cross-reference with other guidelines – for example, for drugs or devices – to clarify requirements. This could be a complex and time-consuming process, so companies need to allow time to review all the requirements or work with a consulting partner who can help to guide them through the application process.
Companies that already have a drug-device combination product on the market in Europe or the United States will find the process of adapting their submission easier than companies that are planning for their product approval for the first time. That is because the regulatory authority in China has been working to bring its requirements more in line with those of the US Food and Drug Administration and the European Medicines Agency. Submissions in China can draw on existing R&D and manufacturing data as long as the data conforms to NMPA requirements.
ProductLife Group’s regulatory consulting subsidiary ELC Group offers expertise on the China market with a team of native Mandarin speakers and established partners in China. ELC’s regulatory experts support companies with their NMPA filings as well as helping manufacturers from China to bring products to market in Europe. The team helps companies cut through the ambiguity with intelligence gathering, including helping to define and classify which category the product falls into and then providing advice on which regulatory requirements need to be met. The team can help applicants handle all the preparatory steps, including coordinating any tests that need to be carried out, managing the timelines, and taking care of the entire registration process if needed.
Since the team has been managing drug and device submissions for some years they have extensive knowledge of the guidances to which the new drug-device combination draft guidelines refer. Having managed applications on behalf of many companies over the years, the team can draw on their previous experience, without revealing confidential information, to provide relevant, intelligence-based recommendations.
Eyeing opportunities in Europe
With a very competitive marketplace in China, a growing number of manufacturers from China are looking to enter other markets to expand coverage. In addition, the life cycle maintenance fee has risen significantly in the United States, leading many companies to consider submitting applications in Europe as they look to reach new markets.
ELC Group’s team of experts can support manufacturers from China looking to enter the European market or help them determine if their product is likely to succeed in Europe. With knowledge of how the development process works in China, the team starts by posing key questions to companies looking to submit applications to the European Medicines Agency or national regulatory agencies to help determine what gaps need to be addressed. The team then puts together a list of steps to tackle before the company considers an application.
Another important consideration is market objectives. Has the company considered which markets to target, or is the manufacturer seeking to enter all European countries? Once the team understands the company’s goals and strategies, experts will put together a clear plan for managing the submission that includes a timeline and Gantt chart. Clients are offered a flexible solution, spanning joint management of the submission up to taking care of the process on their behalf, either across Europe or for specific markets in Europe.
Whether it’s European companies seeking to enter China or Chinese manufacturers looking to expand their market base internationally, ELC’s experts have the know-how and experience to support the submission process.
Author:
Sy Chyi Yeoh is director of business development at ELC Group, a ProductLife Group company. In this role, Sy Chyi develops strategies and supporting analyses for business development projects, assesses client needs and provides cost- and time-efficient solutions, implements solutions and coordinates interaction between clients and ELC’s expert teams.
