On Sept. 1, 2022, China State Administration for Market Regulation (SAMR) published the Administrative Measures for Supervising Online Sales of Drugs (hereafter referred to as the Measures), which will take effect on Dec. 1, 2022.
After regional pilot programs in Hainan and Shenzhen, China finally allows the online sales of prescription drugs nationwide. To ensure safety for selling drugs online, the Measures specifies regulatory requirements for online sellers and third-party online platforms.
1. Qualifications and Obligations of Online Drug Sellers
Drug marketing authorization holders (MAHs) and drug suppliers with the capability to ensure drug safety can become online medical sellers. Before engaging in online sales, they shall obtain drug supplying licenses.
1) The online medical sellers shall fulfill the following obligations1:
Online drug sellers shall conduct online drug sales according to the approved supplying method and scope.
2) MAHs shall only sell the drugs whose marketing authorizations are owned by the MAHs themselves.
3) Drug sellers shall NOT sell the following drugs online: vaccines, blood products, anesthetics, psychoactive drugs, toxic drugs for medical use, radioactive drugs, and chemical precursors in the drug category.
4) Without the retailing qualification, drug retailers shall NOT sell drugs to individuals.
5) Drug retailers shall NOT treat prescription drugs or Category I OTC drugs as giveaways to purchased drugs or other goods.
6) Online drug sellers shall establish systems for
drug quality and safety management;
storage & delivery;
adverse drug reactions (ADRs);
complaints & reports.
Apart from these systems, online drug retailers shall establish online pharmaceutical care systems, where licensed pharmacists and/or other pharmaceutical technical professionals review the prescription, prepare the drugs, and give guidance on the rational use of medicines.
7) Online drug sellers shall report the following information to local medical products administrations:
application (App) name;
drug manufacturing license or drug supplying license, etc.
Sellers should report the changes to the information within ten workdays from the day the changes take place.
2. Prescription Drugs' Sales Supervision and Information Presentation
Though companies can sell prescription drugs online, they must comply with strict rules to avoid sales based on fake prescriptions and the repeated use of one prescription by multiple purchasers.
Sales of Prescription Drugs:
1) Online sales of prescription drugs to individuals shall be based on prescriptions coming from reliable and authentic sources with the customer's real name registration.
2) Online drug sellers shall sign agreements with electronic prescription providers, review the prescriptions, and prepare drugs accordingly. Sellers should mark the used prescriptions to avoid repeated uses.
3) The third-party e-commerce platform shall verify the electronic prescription providers and sign agreements with them.
4) Online drug sellers shall take effective measures to avoid repeated uses of prescriptions if the prescriptions are in paper.
Presentation of Prescription Drugs' Information:
1) Online drug sellers shall highlight the risk alert that "prescription drugs should be bought and used under the guidance of pharmacists" on each drug's information page and make sure the customers know the information before buying the drugs.
2) Online drug sellers shall divide the areas for presenting prescription drugs and OTC drugs, and highlight the drug category (prescription/OTC drug) on the corresponding web pages.
3) Online drug sellers shall NOT present the packages and labels of prescription drugs on the main page and front page for selling prescription drugs.
4) Online drug sellers shall NOT present the prescription drugs' medication package inserts or sell the prescription drugs before the prescriptions pass the review.
3. Obligations of E-commerce Platform Companies
E-commerce platform companies, also known as third-party online sale platform companies, shall fulfill the obligations, including
1) Establishing drug quality and safety management mechanisms, with pharmaceutical technical professionals carrying out the management responsibilities; establishing and implementing systems of
managing drug quality and safety;
presenting drug information;
selling prescription drugs only to customers with real name registration;
keeping transaction records;
complaints & report, etc.
2) Reviewing the online drug sellers' qualification and drug safety assurance capability, establishing files of the sellers, and verifying and updating the files at least every six months;
3) Inspecting and monitoring the sellers' online sales; stopping and reporting the illegalities to the local drug medical products administrations.
4) Stopping the online transaction platform service and the presentation of relevant drug information if the seller commits serious illegalities:
Having no drug sale qualification;
Selling the prohibited drugs mentioned in the item 3) in part 1 of this article;
Selling drugs outside the scope of drug supplying license;
Drug marketing authorization license or drug supplying license suspended due to illegalities;
Committing other severe violations of laws and regulations.
4. BaiPharm's Comment
With the rapid growth of e-commerce, China's pharmaceutical e-commerce market expanded to 226 billion yuan2 (32.63 billion USD) in 2021. The Measures repeals the ban on prescription drugs' online sales, which is expected to boost pharma e-commerce.
Meanwhile, the Measures stipulates detailed obligations for online drug sellers and e-commerce platforms, especially in reviewing prescriptions and presenting prescription drug information. The companies involved in online drug sales need to follow the Measures, otherwise, they may be subject to punishments up to 200,000 yuan in fines if causing severe hazards.