Asia-Pacific Roundup: China publishes guidelines in push to reform regulations by 2027

The Chinese government has published guidelines intended to accelerate the reform of drug and medical device regulation in the country.

China’s General Office of the State Council issued the document and seeks to enhance the legal and regulatory frameworks for drug and medical device supervision improve the quality and efficiency of the review and approval processes for innovative drugs and devices by 2027.

Once those goals have been met, authorities aim to have a modernized regulatory system and support a pharma industry with stronger innovation, creativity and global competitiveness by 2035.

The reforms are built on 24 measures across five key areas: increased support for R&D, enhanged review and approval, improved compliance levels, support for industry expansion, and an adaptable regulatory system.

All the objectives have regulatory elements. To support R&D, China will tilt resources for reviewing and approving products toward key innovative drugs and devices that are needed urgently. The review and approval changes include creating stronger pre-registration guidance while the compliance reforms establish a shorter, 45 working day batch release time limit for seasonal flu vaccines.

China plans to coordinate its requirements with International Council for Harmonisation’s policy as to help companies cooperate and to strengthen regulatory capacity building to ensure its system can adapt to industrial and safety developments. A focus on developing regulatory science is part of the attempt to make the system more adaptable.

The State Council published a series of documents related to the policy, sharing a summary of the plan, the National Medical Product’s Administration (NMPA) interpretation of the guideline, articles by Xinhua News Agency and Guangming Daily and a newspaper opinion piece.

NMPA Notice

India’s CDSCO gives small manufacturers more time to comply with new GMP rules

India’s Central Drugs Standard Control Organization (CDSCO) has given small and medium scale manufacturers until the end of 2025 to comply with new rules on good manufacturing practices (GMPs).

CDSCO published revised GMPs at the end of 2023. Officials gave companies with turnovers of 2.5 billion rupees ($29 million) or more six months to comply with the new rules. Manufacturers with lower annual turnovers had one year to comply. However, when the deadline passed The Economic Times said half of the 10,000 drug manufacturing units in India may have missed the target.

The government responded by extending the deadline for manufacturers below the turnover threshold. Companies need to seek an extension from CDSCO. Applicants need to provide information about their plan for compliance, which must start by the end of March, and justify the request for more time. CDSCO is also asking how much time companies need but will not grant requests beyond the start of 2026.

The Indian Drug Manufacturers’ Association is planning to scale-up capacity-building initiatives to help companies comply with the revised GMP rules, BioSpectrum India reported. The push builds on the 18 workshops and training programs organized by the trade group from 2022 to 2024.

CDSCO Notice

Philippine FDA shares advice on line between drugs and food, GMPs for supplements

The Philippine Food and Drug Administration (FDA) has released guidance on classifying products as drugs or food and on GMP for health supplements.

The classification document describes the criteria that vitamins and minerals need to meet to be classed as a food under Philippine regulations. Products only meet the food classification if they have no clinical therapeutic indications or therapeutic claims and are not used to correct nutritional deficiencies. FDA also set limits on the dosing of vitamins and minerals classed as food and set a transition timeline.

Manufacturers that need to reformulate to meet the classification requirements must file an initial application before their certificate of product registration expires. Companies with less than one year left on their certificates can renew for another two years to provide time to complete reformulation work. All applications received before the order was published will be processed according to the latest GMPs.

FDA published the classification document alongside an order about health supplement manufacturing and registration. The second document describes the GMP aspects of health supplement licensing and the registration process and requirements for the products.

The manufacturing section of the document covers quality management, personnel, premises and equipment and other elements of GMP compliance. FDA expects every health supplement manufacturing establishment to have a quality control system that ensures the product is made in “accordance with adequate conditions and procedures.”

Classification Guidance, GMP Guidance

CDSCO seeks feedback on planned updates to risk classifications for medical devices

India’s CDSCO has released a draft uptake to its risk-based classification of four groups of medical devices for consultation.

The update covers interventional radiology, radiotherapy, oncology and Class A devices. Class A covers non-sterile and non-measuring products and is the largest category in the update, with 803 devices. The Class A devices include stethoscopes, enema bags and testicular temperature regulation underpants.

Across the other three categories, CDSCO has proposed risk classifications for 375 devices. Interventional radiology, the second largest category in the update, mostly features Class B and C devices such as PET systems. Most of the 35 Class D devices are in the radiotherapy section, although CDSCO is also proposing to assign some interventional radiology and oncology products to the high-risk group.

The document is dated 6 January and CDSCO is accepting feedback for 30 days.

CDSCO Notice

Other news:

The Philippine FDA’s ePortal System has experienced “intermittent online problems.” FDA attributed the issues to the implementation of the new schedule of fees and charges, which entailed actions to boost the performance of network infrastructure. FDA Notice

NMPA has approved China’s first stem cell therapy to treat acute graft-versus-host disease in recipients of bone marrow transplants. The agency approved the homegrown mesenchymal stromal cell treatment via its accelerated market registration track. NMPA Notice

Asia-Pacific Roundup: China publishes guidelines in push to reform regulations by 2027

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