Mainland China Pharmaceutical Licensing

This entry applies to the retail, wholesale and manufacture of medicines for human use in Mainland China. Medicines include Chinese medicines, chemical medicines and biological products; separate scope boundaries apply to Chinese herbal medicines and Chinese herbal decoction pieces not subject to approval controls, and to Chinese medicine formula granules.

Business licences, pharmaceutical business or manufacturing licences, drug registration certificates, individual qualifications or registration, import customs clearance and eligibility to handle special categories of medicines are independent of one another. Holders may sell medicines for which registration certificates have been obtained themselves or entrust their sale to others, but must still obtain a pharmaceutical business licence to engage in retail.

Foreign investment access, corporate forms, capital requirements and local rules for establishing a business are not among the nationally uniform conditions verified in this review and must be confirmed with the authorities at the project location.

— Retail: sales directly to consumers.

— Wholesale: sales to manufacturers, pharmaceutical business enterprises or medical institutions.

— Manufacturing: subject separately to manufacturing licensing, GMP and product registration requirements.

The National Medical Products Administration oversees the regulation of medicine distribution, use and manufacture nationwide. Provincial drug regulatory authorities are responsible for manufacturing oversight and for licensing, inspections and penalties relating to wholesalers and retail chain headquarters; municipal and county-level drug regulatory authorities are responsible for licensing, inspections and penalties relating to retailers.

Applications for manufacturing licences must be submitted to the provincial authority where production takes place; applications for distribution licences must be submitted to the authority at county level or above in the relevant locality. Provincial authorities may establish implementing rules, and the actual application channel and inspection checklist must be confirmed locally.

— National rules and standards: National Medical Products Administration and State Administration for Market Regulation.

— Manufacturing, wholesale and chain headquarters: provincial drug regulatory authorities.

— Independent retailers and retail outlets: municipal and county-level drug regulatory authorities.

Retail sale of medicines requires a Drug Distribution Licence. Businesses selling prescription medicines or Class A non-prescription medicines must employ qualified pharmacists or other pharmaceutical technical personnel appropriate to their scope and product range; those selling only Class B non-prescription medicines may employ medicine sales personnel who have passed an assessment by the drug regulatory authority of a city divided into districts.

The licence must specify categories such as prescription medicines and Class A and Class B non-prescription medicines. Prescription medicines must be sold against a prescription and must not be offered on open shelves. If qualified personnel are absent during business hours, a notice must be displayed, and prescription medicines must not be sold without review. Chain headquarters must provide unified quality management for their outlets, whose scope must not exceed that of the headquarters.

— Retailers must not sell medicines prohibited from retail sale, including narcotic drugs, Category I psychotropic drugs and radiopharmaceuticals.

— Category II psychotropic drugs, blood products and similar products require scope approval under special rules.

— Online retail remains subject to online sales rules and prohibitions on the sale of special categories of medicines.

Wholesalers sell medicines to manufacturers, distributors or medical institutions and are licensed, inspected and subject to penalties by provincial drug regulatory authorities. They must have appropriate quality management functions and personnel, qualified pharmacists or other pharmaceutical technical personnel, self-operated warehouses and facilities and equipment, and information systems covering operations, quality control and traceability.

For wholesale sales and purchases, licences, approval documents, test reports and purchase and sales documentation must be provided or checked as required. Products requiring refrigerated or frozen storage must be specified in the scope. Establishing a warehouse in another province must be handled as a change of warehouse address, with coordinated oversight by the provincial authorities in both locations.

— The scope for narcotic drugs, psychotropic drugs and similar products is approved under special rules or requires designated operator status.

— Businesses must not distribute prohibited product categories, including vaccines, preparations made by medical institutions and Chinese medicine formula granules.

— Entrusted sales, storage and transport require separate assessments, agreements and quality arrangements.

Manufacturers of medicinal preparations, active pharmaceutical ingredients and prepared slices of Chinese herbal medicines must apply for a Drug Manufacturing Licence to the provincial drug regulatory authority where production takes place. Applicants must have qualified personnel, appropriate factory premises, facilities, equipment and hygienic conditions, quality management and testing functions with instruments and equipment, and maintain ongoing compliance with GMP.

Manufacturing must follow national or registered standards and approved processes. Licensed particulars such as the manufacturing address and scope must not be changed without authorisation; construction, alteration or expansion of workshops or production lines may trigger a GMP compliance inspection. Marketing authorisation holders manufacturing products themselves must hold a licence; where manufacturing is outsourced, the holder remains responsible for review, release and supervision.

— A manufacturing licence governs the site and scope; it is not a product registration certificate.

— In principle, manufacturing of blood products, narcotic drugs and similar products must not be outsourced, unless otherwise provided.

— Manufacturing licences are now administered using QR codes on electronic licences.

Distribution licensing requires enterprise personnel and quality management arrangements appropriate to the business; there is no fixed nationwide staffing quota that can be applied directly. Wholesalers must have qualified pharmacists or other pharmaceutical technical personnel and quality-related posts; corresponding requirements also apply to the retail sale of prescription medicines or Class A non-prescription medicines.

Manufacturing licensing requires pharmaceutical and engineering technical personnel and skilled workers, and involves roles such as the heads of production and quality and the quality authorised person. An individual's licensed pharmacist qualification or registration is distinct from an enterprise licence. The full individual registration process has not been verified in this review and should be confirmed through the relevant local authority's channels.

— Retail sale of prescription medicines and Class A non-prescription medicines: appropriately qualified personnel.

— Class B non-prescription medicines only: sales personnel who have passed an assessment by the authority of a city divided into districts.

— Manufacturing: quality, production and release roles should be incorporated into the quality system.

Retailers must have appropriate business, display and storage facilities and hygienic conditions. Medicines must be separated from non-medicinal products, and retail sales in supermarkets or similar premises require a separate area. Wholesalers must have self-operated warehouses, modern logistics facilities and information systems covering quality control and traceability.

Storage and transport measures must reflect packaging, quality characteristics and temperature-control requirements. Products requiring refrigerated or frozen storage must have suitable equipment, with monitoring records retained. Manufacturing sites must maintain ongoing GMP compliance; changes to manufacturing addresses or scope, and alterations or expansions of workshops or production lines, may trigger licence amendments or GMP inspections.

— Distribution applications generally include premises and storage information, floor plans, and documentation of ownership or rights of use.

— Wholesale warehouses in another province are handled as changes of warehouse address.

— No nationally uniform numerical floor-area requirement for pharmacies or warehouses has been verified.

To establish a medicine distribution enterprise, first obtain a business licence, then apply for a distribution licence. Documents include the application form, quality management and responsible-person documentation, pharmaceutical personnel qualifications and appointment documents, mode and scope of operations, quality procedures and a facilities list, premises and warehouse floor plans, and documentation of ownership or rights of use.

After a distribution application is accepted, technical review and on-site inspection are conducted. Manufacturing applications must be submitted in accordance with national requirements to the local provincial authority, which conducts technical review, assessment and on-site inspection. Product registration follows a separate drug registration procedure; manufacturing licensing does not replace product registration or pre-marketing inspection.

— Distribution: business licence, licensing documents, review and inspection, decision and licence issuance.

— Manufacturing: provincial application and GMP-related review and inspection.

— Products: registration certificates, marketing authorisation holders and import procedures are managed separately.

A distribution licence is valid for five years. The competent authority must make a decision within 20 working days of accepting the application, excluding time spent on technical review, on-site inspection and rectification. For retail sale of Class B non-prescription medicines only, a licence may be issued on the same day if the requirements are met, but technical review and on-site inspection will still be conducted within 3 months.

A manufacturing licence is valid for five years. The provincial authority must make a decision within 30 working days of accepting the application, excluding time spent on technical review, assessment, on-site inspection and rectification. The central texts verified do not specify a nationally uniform fee amount; this must be confirmed with the authority accepting the application.

— Distribution licence renewal applications are generally submitted between 6 months and 2 months before expiry.

— Manufacturing licence renewal applications are submitted 6 months before expiry.

— No commitment is made regarding actual completion dates or local fees.

Distribution enterprises must operate at the approved address and within the approved mode and scope, and establish a quality system covering the entire process. Purchase, sales, storage, transport and quality records must be complete and accurate. Relevant credentials, documentation and records must be retained for at least 5 years and at least 1 year after the medicines' expiry dates. Distribution enterprises must implement traceability, purchase and sales verification, and quality management for storage and transport.

Manufacturers must maintain ongoing GMP compliance and conduct risk management, annual self-inspections, supplier audits and quality reviews. Personnel in direct contact with medicines must undergo annual health checks. Marketing authorisation holders must also fulfil their post-marketing, pharmacovigilance and reporting responsibilities under the law.

— Distribution GSP: quality systems, records, traceability, verification and temperature control.

— Manufacturing GMP: processes, sites, validation, testing, release and change control.

— When risks are identified, operations must be stopped, reports made, recalls conducted or assistance provided with measures, as required by law.

The operating address, scope, mode of operations and warehouse address on a distribution licence are licensed particulars. Changes require prior application, and the issuing authority must decide within 15 days of acceptance. Changes to registered particulars, including the enterprise name, unified social credit code, legal representative, principal person responsible and head of quality, require an application to amend the registration within 30 days of the change.

Manufacturing licence particulars such as the manufacturing address and scope must not be changed without approval. Address or scope changes may also involve GMP inspections and updates to registration certificate annexes. Licences must not be forged, altered, rented out, lent or bought and sold. There is no uniform central rule under which an ordinary share transaction automatically transfers a licence upon completion; each matter should be verified individually.

— Acquisition of a retailer by another chain's headquarters is handled through the distribution licence amendment procedure.

— Transfer of a drug registration certificate requires an application to the drug regulatory authority under the State Council.

— Changes to the entity, personnel, address, scope and marketing authorisation holder should be assessed separately.

In principle, medicines placed on the market in Mainland China require a drug registration certificate approved by the drug regulatory authority under the State Council, except for Chinese herbal medicines and prepared slices of Chinese herbal medicines not subject to approval administration. Marketing authorisation holders are responsible for medicines throughout their life cycle; product registration, manufacturing licensing and distribution licensing should be checked in parallel.

Medicines must be imported through ports authorised for medicine imports. The importing enterprise must file with the drug regulatory authority at the port of entry and obtain a customs clearance document; customs must not release the goods without that document. Narcotic drugs and psychotropic substances are subject to designated production and distribution arrangements. Narcotic drugs and Class I psychotropic substances must not be sold by retail; their import and export require a permit from the drug regulatory authority under the State Council.

— Products: registration certificates, marketing authorisation holders, registered standards and product changes.

— Imports: port filing, customs clearance documents, customs procedures and possible port inspections.

— Controlled medicines: designated operator status, scope, storage and transport, distribution flows, and import and export documents.