On May 20, 2024, China's Center for Drug Reevaluation under the NMPA released the draft Guidelines on the Scope of Applications for Switching Prescription Drugs to Over-the-Counter (OTC) Drugs for public consultation. The draft outlines the key criteria and exclusions for such drug switching.
According to the draft, MAHs or the agents designated by MAHs of imported drugs can apply for switching the prescription drugs to OTC if the drugs meet the following conditions:
Comply with the evaluation guidance principles and technical requirements for switching to OTC status.
Are suitable for consumer self-awareness, self-judgment, self-medication, and self-monitoring.
Have been widely used clinically in China and have a good safety profile (including preparations or ingredients).
However, the guidance excludes several categories of drugs from switching, including:
Drugs used for emergency treatment and other diseases that are not suitable for self-treatment by consumers, such as drugs for the treatment of tumors, glaucoma, gastrointestinal ulcers, mental illness, diabetes, liver diseases, kidney diseases, prostate diseases, immune diseases, cardiovascular and cerebrovascular diseases, and sexually transmitted diseases.
Drug formulations that are inconvenient for consumers to use themselves, such as injections and implants.
Drugs that require professional medical supervision and guidance during use, such as anticoagulants, antidotes, and vaccines.
Drugs that need to be stored under special conditions, such as those requiring strict light shielding and low-temperature storage.
Systemic antimicrobial drugs and hormones (except contraceptives).
Traditional Chinese medicine containing toxic herbs that are not allowed to be switched as stipulated.
Active pharmaceutical ingredients, pharmaceutical excipients, Chinese herbs, and decoction pieces.
Special management drugs such as medical toxic drugs, narcotic drugs, psychotropic drugs, and radioactive drugs as stipulated.
Other drugs that do not meet the requirements for OTC drugs.
The draft is currently open for public feedback and comments until June 22, 2024. Anyone who wishes to provide suggestions on the draft can submit their comments to the email address zycdr@cdr-adr.org.cn.
