China proposes to speed up FSMPs assessment process, prioritise rare disease related products

By Tingmin Koe contact

- Last updated on GMT

China's State Administration for Market Regulation has proposed to speed up the amount of time for assessing FSMPs undergoing registration. ©Getty Images
China's State Administration for Market Regulation has proposed to speed up the amount of time for assessing FSMPs undergoing registration. ©Getty Images

Related tags: China, FSMP, regulations

China has proposed new changes to its management of Foods for Special Medical Purposes (FSMPs), such as prioritising the assessment and registration of products catered to patients suffering from rare diseases, as well as reducing the duration of product assessment.

The country’s State Administration for Market Regulation (SAMR) announced the list of proposed changes on October 18​, which is now open for public feedback until November 18.

According to China’s regulations, FSMPs are developed to meet the special dietary requirements of individuals with digestion and nutrient absorption disorders, metabolic disorders, or patients suffering from certain diseases.

The current regulations came into force since July 2016.

However, since then, the regulator has observed that more improvements could be made to the product registration and assessment processes, as well as the legal liability of parties registering the products.

“[We will] need to further strengthen the enterprises’ product innovation, manufacturing, testing and other key areas relevant to [FSMPs] product registration process.

“[We will] raise the technical assessment standards, improve the process of product registration, implement the strictest regulations and demand accountability, to lead high quality development in the FSMPs industry,”​ the SAMR said.

Firstly, the SAMR has proposed to prioritise the assessment and registration of new FSMPs that are urgently needed in clinical settings or are catered to patients suffering from rare diseases.

In addition, the SAMR will shorten the duration required to assess the registration of such products – from the current 40 to 30 working days.

This will help speed up the registration process of such products.

Similar to the existing requirement, there will be onsite inspection and sampling of FSMPs that have filed for registration.

If required, the regulator would also inspect the ingredient and food additive firms supplying ingredients to the FSMPs.

Label requirements

The SAMR has also proposed stricter product labelling standards, where the labelling should emphasise that the product is a FSMP. This is to prevent consumers from confusing FSMPs with general food products.

One special feature of FSMPs is the registration number, which starts with “TY” – which is the code for FSMPs, followed by eight digits. 

The FSMPs' product labelling should also emphasise the warning statement, including how consumers should use the product under the guidance of doctors and clinical nutritionists.

Halting assessment

The SAMR has also proposed nine scenarios whereby the authority will not proceed with the assessment of FSMPs registrations. 

These scenarios include 1) the use of fake ingredients, 2) ingredients used in the product lacked safety, nutrition value, clinical effectiveness, 3) registrants lacked the ability to develop, manufacture, or test the product, 4) registrants failed to submit further documents within the stated period or provided documents that did not meet relevant requirements.

Other scenarios are 5) failing to facilitate, rejecting, or not cooperating with onsite inspection and sample testing and 6) registrants using the same formula to register a product with a different name.

Digital certs

On the other hand, companies with successful FSMP registration will be given electronic certificates, with a validity of five years.

These electronic certificates will bear the same legal power as the printed versions.

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