Introduction

On March 28, 2026, China's National Medical Products Administration (NMPA) announced the reclassification of two traditional Chinese medicines (TCMs)—Qinghuo Capsules and Biantong Tablets—from prescription (Rx) to over-the-counter (OTC) status. This move not only enhances domestic retail efficiency but also signals a strategic shift for TCM exports, particularly in markets like Southeast Asia, the Middle East, and Latin America, where plant-based medicines are widely accepted and OTC regulations are well-defined. The decision underscores China's push to streamline TCM globalization through a 'clinical evidence + quality standards + OTC positioning' model, reducing registration barriers and channel costs abroad.

Event Overview

The NMPA's March 28 announcement confirmed the OTC switch for Qinghuo Capsules (a heat-clearing formula) and Biantong Tablets (a constipation relief product). Both drugs have established domestic clinical use and safety profiles. The reclassification eliminates the need for physician prescriptions in China, enabling direct retail and e-commerce sales. Internationally, the OTC designation aligns with regulatory frameworks in target markets, where non-prescription status simplifies registration and distribution.

Impact on Key Sub-Sectors

1. TCM Exporters and Cross-Border Traders

The OTC shift lowers entry barriers in overseas markets, particularly where regulators recognize China's drug classifications. Exporters can now leverage simplified registration pathways (e.g., ASEAN's mutual recognition agreements) to accelerate market entry. Companies should prioritize markets like Vietnam, Indonesia, and the UAE, where OTC herbal products dominate pharmacy shelves.

2. Domestic Retail and E-Commerce Platforms

Domestically, the change boosts accessibility through pharmacies and online channels. Retailers may see higher turnover for these products, but competition will intensify. Platforms like JD Health and Alibaba Health should update category strategies to highlight OTC benefits (e.g., self-care positioning).

3. Raw Material Suppliers

Increased production demand for ingredients like rhubarb (used in Biantong Tablets) could strain supply chains. Suppliers should audit stock levels and explore contracts with GMP-certified manufacturers to meet quality requirements for international markets.

Actionable Insights for Stakeholders

1. Monitor Regulatory Follow-Ups

Track NMPA updates on labeling and advertising rules for the newly OTC products. Overseas, confirm whether target countries automatically recognize China’s OTC designations or require additional dossiers.

2. Prioritize Markets with Clear OTC Pathways

Southeast Asia’s harmonized herbal medicine regulations (e.g., Thailand’s THP list) offer faster approval timelines. Avoid regions like the EU, where OTC status alone doesn’t bypass traditional herbal registration complexities.

3. Strengthen Evidence-Based Marketing

OTC status abroad often hinges on documented safety. Compile existing pharmacovigilance data and invest in localized consumer education (e.g., Arabic-language materials for the Middle East).

Editor’s Observation

This reclassification is more than a regulatory tweak—it’s a calculated step toward TCM globalization. By aligning with OTC-friendly markets, China reduces reliance on Rx pathways that often face skepticism abroad. However, success hinges on two factors: (1) consistent quality control to uphold international trust, and (2) agile distribution partnerships to capitalize on the OTC advantage. The industry should view this as a pilot for future Rx-to-OTC conversions of evidence-backed TCMs.

Conclusion

The NMPA’s decision reflects a pragmatic approach to TCM export challenges. While immediate gains will accrue to domestic retailers, the long-term play lies in leveraging OTC status to penetrate price-sensitive emerging markets. Stakeholders should treat this as a template for future conversions, but avoid overestimating short-term overseas traction—market-specific localization remains critical.

Sources

• National Medical Products Administration (NMPA) Announcement, March 28, 2026
• Note: Overseas regulatory reciprocity mechanisms (e.g., ASEAN’s TCM recognition) require ongoing verification with local authorities.