As 2025 begins, industries worldwide face a rapidly evolving regulatory landscape. Emerging trends, stricter compliance requirements, and new opportunities are redefining the global market, bringing both challenges and strategic possibilities for businesses.

Our “2025 Regulatory Insights” series offers an in-depth look at critical updates and practical strategies to help you navigate these changes with confidence.

1. China: Health-Based Exposure Limits (HBEL) for Co-Production Risk Assessments

   Health-Based Exposure Limit (HBEL)–based risk assessments are gaining prominence in China due to their scientific rigor. The use of HBEL allows for more reliable evaluations and can reduce the risk of secondary assessments. Ensuring comprehensive and accurate HBEL reports will be crucial for the smooth progression of production and research projects.

Compliance Alert:
Pharmaceutical companies should ensure including PDE (Permitted Daily Exposure) reports in the risk assessment when manufacturing medicinal products in shared facilities and that these PDE reports adhere to the required standards. Ensuring compliance now will avoid complications during GMP audits.

2. China: 2025 Edition of the Chinese Pharmacopoeia to Be Released

   The 2025 edition of the Chinese Pharmacopoeia (Pharmacopeia of the People’s Republic of China) is expected to be published in March 2025 and implemented in October 2025. This updated version will introduce new standards and requirements for drug production and testing.

Compliance Alert:
Pharmaceutical companies should closely monitor the release of the 2025 edition and adjust their operations in line with the new requirements to ensure full regulatory compliance once the new edition is implemented.

3. China: New Regulations on Pharmaceutical Excipients and Packaging Materials to Be Enforced in 2025

   On January 2, 2025, China’s National Medical Products Administration (NMPA) released two appendices to the Good Manufacturing Practice for Pharmaceutical Products (2010 Revision), specifically targeting pharmaceutical excipients and packaging materials respectively. These appendices will come into effect on January 1, 2026.

Compliance Alert:
Pharmaceutical companies involved in the production of excipients and packaging materials should begin updating their facilities and quality management systems to meet the new regulatory requirements before the January 2026 deadline.

4. China Standardizes Requirements for Domestic Responsible Persons Designated by Overseas MAHs

On November 14, 2024, China’s National Medical Products Administration (NMPA) issued the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders (MAH) of Drugs.

The Provisions establish a comprehensive framework for the qualifications and requirements of domestic responsible persons designated by overseas drug MAHs and provide clear guidelines for reporting information about domestic responsible persons.

Effective July 1, 2025, all overseas-manufactured drugs must adhere to the Provisions, including the inclusion of the domestic responsible person’s name, address, and contact details on the drug package insert.

5. China: New Re-registration Requirements for Domestic Manufactured Drugs Starting in 2025

   On October 11, 2024, China’s National Medical Products Administration (NMPA) published the Application Procedures and Documentation Requirements for the Re-registration of Domestically Produced Drugs, effective January 1, 2025.

How REACH24h Can Help

At REACH24H, we are dedicated to providing comprehensive regulatory support for pharmaceutical companies navigating the complexities of China’s evolving pharmaceutical regulations. Our team of experts stays updated on the latest changes to ensure your business stays compliant and minimizes risks.

We can assist with:

• Preparing for Health-Based Exposure Limit (HBEL)-based risk assessments and ensuring the accuracy of your PDE (Permitted Daily Exposure) reports to meet GMP audit requirements.
• Monitoring the release of the 2025 Chinese Pharmacopoeia and advising on necessary adjustments to your production and testing procedures.
• Helping you comply with the new regulations on pharmaceutical excipients and packaging materials, ensuring that your facilities and systems are updated ahead of the January 2026 deadline.
• Assisting in the designation of domestic responsible persons for overseas Marketing Authorization Holders (MAH) and ensuring compliance with the new reporting requirements.
• Supporting you in meeting the re-registration requirements for domestically produced drugs and guiding you through the documentation process.

With REACH24H’s specialized knowledge and hands-on approach, we ensure that your business stays ahead of regulatory changes, avoiding potential disruptions and promoting a smooth path to compliance. Contact us today to learn how we can support your operations in China and beyond.