By Fineline Cube 
The National Medical Products Administration (NMPA) issued a draft of its Compliance Guidelines for Online Retail of Prescription Drugs, inviting public comment until September 15. The guidelines aim to strengthen drug‑safety oversight of e‑pharmacies and ensure that all prescription sales are traceable and sourced from legal channels.
Key Pillars of the Draft
| Area | Mandate |
|---|---|
| Safety & Quality | Companies must shoulder full responsibility for drug safety and continuously enhance their quality‑management systems across procurement, storage, sales, and transport. |
| Licensing & Transparency | Online retailers must be licensed by regulatory authorities and disclose details (name, website, domain, IP address, and drug‑business licence) to the NMPA. Any changes must be reported within 10 working days. |
| Operational Standards | Establish an online pharmaceutical service system that aligns with Good Pharmacy Practice (GPP) guidelines and its appendices. |
| Prescription Review Limits | Pharmacists are capped at 300 prescriptions per day; exceeding this triggers intensified monitoring of review quality and behavior. |
| Prohibited Activities | Selling unapproved drugs or offering storage/transport services for them is illegal. Platforms facilitating such activities face severe liability. |
Implications for Online Pharmacies
- Compliance Burden – Retailers must overhaul IT systems to capture and report the required data in real time.
- Risk‑Based Monitoring – Third‑party platforms are encouraged to implement dynamic risk‑analysis tools to flag non‑standard prescriptions, inappropriate medication use, irregular orders, and multiple purchases from a single account.
- Quarterly Audits – Platforms should conduct retrospective reviews of prescription usage and sales to identify and mitigate risks promptly.
Industry Reactions
- Pharmaceutical Companies applaud the focus on safety but caution that the reporting requirements may strain smaller e‑pharmacies.
- Retail Platforms are expected to invest in compliance‑automation solutions to meet the new thresholds and avoid potential penalties.
Next Steps
- Public Commentary – Stakeholders can submit comments until September 15 via the NMPA portal.
- Finalization – The NMPA will review feedback and publish the final guidelines, likely in the first half of 2026.-Fineline Info & Tech