CDE Issues Three Draft Guidelines for Public Comments on Geriatric Drug Development

With the acceleration of the global aging process, on May 19, 2025, the Center for Drug Evaluation (CDE) issued three draft guidelines for public comments:

"General Principles and Considerations for Geriatric Design in Innovative Drug Development"
"Guidelines for Writing Geriatric-related Information in Drug Instructions"
"Key Elements and Trial Design Considerations for the Inclusion of the Elderly Population in Clinical Trials of Innovative Drugs"

These news provides a comprehensive analysis the core content of these three draft guidelines to empower pharmaceutical companies and understand the latest requirements of Chinese regulatory authorities for geriatric drug development.

Introduction

From a regulatory perspective, these three documents are an important advancement of the geriatric pharmaceutical framework developed in recent years. In terms of scope of application, these three documents cover the entire life cycle of innovative drug development.

Please note that these policy documents are still in the public comment stage, although the deadline for public comments has now expired. Therefore, the finally implemented regulations may still change prior to enactment.

Core Principles and Design Requirements for Geriatric Drug Development

The draft guidelines state the core principle of "patient-centeredness," requiring pharmaceutical companies to systematically incorporate the characteristics of elderly patients (such as cognitive/sensory decline, multimorbidity, and polypharmacy) throughout the drug life cycle, from discovery to post-marketing. For foreign pharmaceutical companies, understanding and implementing this framework is the foundation for developing geriatric-friendly drugs in China.

Key Design Elements and Requirements:

Deep User Involvement: Emphasizes integrating feedback mechanisms from elderly patients into the entire R&D process, especially in aspects such as dosage forms, dosing regimens, and packaging through participatory research. It is recommended that foreign pharmaceutical companies establish a Chinese Elderly Patient Advisory Committee or increase Chinese representation in global plans.
Refined Formulation Design:
• Swallowing Difficulties: Prioritize small tablets, orally disintegrating agents, or liquid formulations.
• Cognitive/Operational Abilities: Use differentiated color coding, easy-to-open packaging, and simplified dosing devices.
• Usage Scenarios: Evaluate convenience in assisted living facilities or home care environments. A specific geriatric suitability assessment for the Chinese market is required.
Early R&D Considerations: Encourages the consideration of geriatric factors in the molecular screening and preclinical stages (e.g., evaluating pharmacokinetics in aging models, focusing on targets that may exacerbate geriatric symptoms), achieving "front-end loading," and requiring companies to adjust their pipeline evaluation mechanisms.
Addressing Multimorbidity and Polypharmacy: Evaluate potential drug-disease/drug-drug interactions in the drug design phase (especially for commonly used geriatric drugs such as anticoagulants and antihypertensives), and establish a database of Chinese elderly patient medication habits.
Application of Innovative Technologies: Encourages the use of digital health technologies (monitoring adherence), intelligent dosing devices (reducing errors), and decentralized clinical trials (DCT) to enhance geriatric levels, providing opportunities for foreign pharmaceutical companies to introduce validated technologies.
Enhanced Regulatory Communication: The NMPA encourages early communication (e.g., pre-IND meetings) on geriatric design (especially innovative methods and inclusion of special populations), which is a policy benefit for foreign pharmaceutical companies to reduce risks.

Table 1: Key Design Elements for Geriatric Drug Development

Design dimension Special considerations for older patients Strategies for overseas pharmaceutical companies Dosage form selection Difficulty swallowing, decreased hand dexterity Development of age-friendly dosage forms such as tablets, oral liquids, patches, etc. Dosing regimen Cognitive decline and poor adherence Simplify the frequency of administration (e.g., QD administration) and develop combination formulations Packaging design Decreased vision and limited ability to operate Large-print labels, easy-to-open packaging, and differentiated color coding Drug delivery device Low technology acceptance and reduced learning ability Develop one-button smart devices and integrated medication reminder functions Safety Assessment Multi-disease coexistence, polypharmacy Strengthen drug interaction studies and geriatric-specific toxicity assessments

Normative Requirements for Clinical Trial Design in the Elderly Population

The draft guideline "Key Elements and Trial Design Considerations for the Inclusion of the Elderly Population in Clinical Trials of Innovative Drugs" addresses the long-standing issue of underrepresentation of the elderly population in clinical trials by proposing systematic solutions. When designing trials, the physiological characteristics, pathological conditions, and medication needs of the elderly population should be fully considered. For example, in the selection of participants, the age range should be reasonably determined, and the inclusion of patients over 75 years old is encouraged to cover the full age range of the elderly population.

At the same time, attention should be paid to the common multimorbidity and polypharmacy in the elderly population to ensure that the trial results truly reflect the safety and efficacy of the drug in complex clinical backgrounds. During the trial process, the trial process should be optimized, and a decentralized clinical trial (DCT) model should be adopted, combined with remote monitoring and digital health technologies (such as wearable devices) to reduce the limitations of mobility in elderly patients and increase their participation.

This document aims to implement the ICH E7 guideline requirements, improve the scientific and reliability of geriatric data in Chinese innovative drug clinical trials, and provide sufficient basis for the rational use of drugs in elderly patients. For foreign pharmaceutical companies, understanding these special requirements is crucial for conducting geriatric clinical trials in China that meet international standards.

Specific Requirements for Geriatric-friendly Drug Instructions

The draft guideline clearly states that the simplified version should quote the core content of the complete version of the instructions without modifying the medical information, focusing on key information such as dosage, contraindications, and interactions that are of greatest concern to elderly patients. In addition to the paper version of the instructions, companies should also provide electronic, audio, large-font, and even Braille versions to meet the needs of different elderly patients. It is also required to print a QR code on the product packaging or simplified version of the instructions, through which the electronic version of the complete instructions can be obtained by scanning.

Furthermore, as experience with the use of drugs in the elderly population accumulates, companies should promptly update the geriatric-related information in the instructions, especially newly discovered safety signals or dosage adjustment recommendations. Companies are encouraged to establish a monitoring and revision process for geriatric medication information to ensure that the content of the instructions remains consistent with the latest clinical evidence.

Summary

Although the three draft guidelines have not yet been finalized, their core framework has been essentially clarified. Companies can conduct a gap analysis in advance to identify the match between existing product pipelines and geriatric requirements. For products in the early stages of research and development, the geriatric requirements in China should be incorporated into the global development plan to avoid the high cost of later retrofitting. For marketed products, the priority of geriatric-friendly instruction transformation should be assessed, with commonly used geriatric drugs (such as antihypertensive, hypoglycemic, and anticoagulant drugs) being prioritized.

For overseas pharmaceutical companies, consulting with professional companies such as Cisema can further understand the detailed regulatory requirements and facilitate the formulation of the next steps.

Further Information

To read the original announcements released by the Center for Drug Evaluation (CDE) on May 19, 2025, please refer to the following: General Principles and Considerations for Geriatric Design in Innovative Drug Development, Guidelines for Writing Geriatric-related Information in Drug Instructions, and Key Elements and Trial Design Considerations for the Inclusion of the Elderly Population in Clinical Trials of Innovative Drugs.

If you are a pharmaceutical company with questions about how these draft guidelines may affect your product development or clinical trials for the China market, please contact Cisema.