China Strengthens Vetting on Medicine Advertisements

China
On 22 November 2000, the State Pharmaceutical Supervision and Administration of China (SPSAC) issued a Circular on Strengthening the Examination and Approval of Medicine Advertisements (Circular). This Circular reiterates key issues from old rulings in relation to the vetting of medicine adverts which aim to crack down on the current rampant illegal practices in this field.

Authorities in charge

The State Administration for Industry and Commerce (SAIC) and its local counterparts are the authorities in charge of the general supervision and administration of advertisements (Supervisory Authorities). The SPSAC and its provincial counterparts are the authorities in charge of the examination and approval of medicine adverts (Examination Authorities).

The Examination Authorities are required to carry out their work under the direction of the Supervisory Authorities. The Examination Authorities have to file approval forms for medicine adverts with the Supervisory Authorities at the same level and where there have been violations, it is up to the Examination Authorities to refer the illegal medicine adverts to the Supervisory Authorities to deal with.

Where adverts are to be released in key media which are defined by an attached catalogue, or where adverts are placed for new medicines or imported medicines, the SPSAC must be consulted for approval. For other medicine adverts, provincial level authorities have the necessary jurisdiction.

Qualification of advertisers

The advertisers for medicines must be the legal manufacturers or distributors of the advertised medicines. If the distributors are to be the advertisers, they must submit an original authorization from the manufacturers to the effect that they have been engaged by the manufacturers to distribute and advertise the medicines. Otherwise, an application from distributors will be rejected.

Applicants for imported medicine advertisements may delegate authority to their local distributors or advertisement agents to comply with the vetting procedures.

Restrictions on advertised medicines

Article 2 of the Vetting Standards for Medicine Advertisements sets out a list of medicines that are not allowed to be advertised.

  • Anesthesia medicines, medicines for mental diseases, poisonous or radioactive medicines
  • Medicines for tumours, AIDS, sexual dysfunction, birth control and epidemic prevention
  • Fake or inferior medicines prescribed by the PRC Law on Medicine Administration
  • Medicines for detoxification and other special medicines provided by the state administrative authorities for public health
  • Medicines without manufacturing approval from the authorities
  • Medicines expressly prohibited by the authorities from manufacturing or distribution and medicines manufactured on a pilot basis
  • Medicines without registered trademarks except Chinese traditional medicines

Application procedures and required documents

Applicants for medicine adverts must apply to the competent Examination Authorities for approval. Relevant documents which need to be filled out or submitted include:

1. The Vetting Form of Medicine Advertisements
2. Copies of Business Licenses of the applicant and/or the manufacturer
3. Medicine Manufacturing Permit or Medicine Distribution Permit
4. Manufacturing approval, approved quality standards, Facts Statement and packaging of the medicine to be advertised
5. Trademark Registration Certificate and approval of commercial name of the medicine if any
6. Other documents that may be required

If imported medicines are involved, items 1, 2, 4 and 6 above are required and, in addition, a Registration Certificate for Imported Medicines is needed.

The vetting process is divided into two stages, the preliminary vetting and the final vetting. The preliminary vetting relates to examination of the submitted documents and the draft scripts of the adverts while the latter deals with the finalized adverts. Applicants may skip the preliminary vetting and go directly through the final one. If the adverts pass the final vetting stage, the Examination Authorities will assign an Approval Identification Number (Ad Number) to the advertised medicine. The Advert Number remains valid for one year and may be renewed upon application.

Restrictions and requirements on the contents of the adverts

The contents of the medicine adverts shall be in line with the Facts Statement approved by relevant authorities for public health.

Certain items must be included in the adverts, such as the Ad Number, Manufacturing Approval Number. The commercial name of the medicine cannot be advertised separately, which must be accompanied by the universal name of the medicine. Adverts for prescription medicines must indicate "To be purchased or taken under the direction of doctors."

Certain contents cannot be included in the adverts. Generally speaking, arbitrary conclusions or guarantees on the effects of the medicine, derogatory comments on similar products, comparisons with similar products, comparisons between situations before and after taking the medicine, absolute wordings with no scientific basis, references made to medical research institutions, academic institutions or experts and so on cannot appear in advertisements.

Enforcement Procedures

Advertisement agents must design and produce the adverts in compliance with the approved contents by the Examination Authorities at the preliminary stage, if any. Persons who issue or publish the adverts for the advertisers must check and verify the original Vetting Form of Medicine Advertisements approved by the Examination Authorities and contents of the adverts prior to issuance or publication.

If the Examination Authorities find any violation, such as published adverts that have not complied with prior vetting or the contents of which go beyond what is approved, they should immediately inform the Supervisory Authorities and ask them to deal with them.

Violators will be punished according to the relevant provisions in the PRC Law of Advertisement and PRC Law on Medicine Administration. The authorities may order the violators to make corrections, suspend the adverts in question, forfeit advertisement agent fees and impose fines up to five times of the advertisement agent fees. For the advertising agents or publishers, they may even be disqualified to engage in advertisement business; for the advertisers, which are medicine manufacturers or distributors, their Medicine Manufacturing Permit or Distribution Permit may also be suspended in case of serious offenses.

Conclusions

Medicines directly relate to people's health and life. Inappropriate medicine adverts may mislead people into choosing the wrong medicine. Advertisements for medicines available over the counter play an especially big role in affecting people's choice of particular medicines. It is therefore appropriate and necessary to regulate medicine adverts and to impose severe penalties for breach of those.

Authorities in charge

The State Administration for Industry and Commerce (SAIC) and its local counterparts are the authorities in charge of the general supervision and administration of advertisements (Supervisory Authorities). The SPSAC and its provincial counterparts are the authorities in charge of the examination and approval of medicine adverts (Examination Authorities).

The Examination Authorities are required to carry out their work under the direction of the Supervisory Authorities. The Examination Authorities have to file approval forms for medicine adverts with the Supervisory Authorities at the same level and where there have been violations, it is up to the Examination Authorities to refer the illegal medicine adverts to the Supervisory Authorities to deal with.

Where adverts are to be released in key media which are defined by an attached catalogue, or where adverts are placed for new medicines or imported medicines, the SPSAC must be consulted for approval. For other medicine adverts, provincial level authorities have the necessary jurisdiction.

Qualification of advertisers

The advertisers for medicines must be the legal manufacturers or distributors of the advertised medicines. If the distributors are to be the advertisers, they must submit an original authorization from the manufacturers to the effect that they have been engaged by the manufacturers to distribute and advertise the medicines. Otherwise, an application from distributors will be rejected.

Applicants for imported medicine advertisements may delegate authority to their local distributors or advertisement agents to comply with the vetting procedures.

Restrictions on advertised medicines

Article 2 of the Vetting Standards for Medicine Advertisements sets out a list of medicines that are not allowed to be advertised.

  • Anesthesia medicines, medicines for mental diseases, poisonous or radioactive medicines
  • Medicines for tumours, AIDS, sexual dysfunction, birth control and epidemic prevention
  • Fake or inferior medicines prescribed by the PRC Law on Medicine Administration
  • Medicines for detoxification and other special medicines provided by the state administrative authorities for public health
  • Medicines without manufacturing approval from the authorities
  • Medicines expressly prohibited by the authorities from manufacturing or distribution and medicines manufactured on a pilot basis
  • Medicines without registered trademarks except Chinese traditional medicines

Application procedures and required documents

Applicants for medicine adverts must apply to the competent Examination Authorities for approval. Relevant documents which need to be filled out or submitted include:

1. The Vetting Form of Medicine Advertisements 2. Copies of Business Licenses of the applicant and/or the manufacturer 3. Medicine Manufacturing Permit or Medicine Distribution Permit 4. Manufacturing approval, approved quality standards, Facts Statement and packaging of the medicine to be advertised 5. Trademark Registration Certificate and approval of commercial name of the medicine if any 6. Other documents that may be required
7. If imported medicines are involved, items 1, 2, 4 and 6 above are required and, in addition, a Registration Certificate for Imported Medicines is needed.

The vetting process is divided into two stages, the preliminary vetting and the final vetting. The preliminary vetting relates to examination of the submitted documents and the draft scripts of the adverts while the latter deals with the finalized adverts. Applicants may skip the preliminary vetting and go directly through the final one. If the adverts pass the final vetting stage, the Examination Authorities will assign an Approval Identification Number (Ad Number) to the advertised medicine. The Advert Number remains valid for one year and may be renewed upon application.

Restrictions and requirements on the contents of the adverts

The contents of the medicine adverts shall be in line with the Facts Statement approved by relevant authorities for public health.

Certain items must be included in the adverts, such as the Ad Number, Manufacturing Approval Number. The commercial name of the medicine cannot be advertised separately, which must be accompanied by the universal name of the medicine. Adverts for prescription medicines must indicate "To be purchased or taken under the direction of doctors."

Certain contents cannot be included in the adverts. Generally speaking, arbitrary conclusions or guarantees on the effects of the medicine, derogatory comments on similar products, comparisons with similar products, comparisons between situations before and after taking the medicine, absolute wordings with no scientific basis, references made to medical research institutions, academic institutions or experts and so on cannot appear in advertisements.

Enforcement Procedures

Advertisement agents must design and produce the adverts in compliance with the approved contents by the Examination Authorities at the preliminary stage, if any. Persons who issue or publish the adverts for the advertisers must check and verify the original Vetting Form of Medicine Advertisements approved by the Examination Authorities and contents of the adverts prior to issuance or publication.

If the Examination Authorities find any violation, such as published adverts that have not complied with prior vetting or the contents of which go beyond what is approved, they should immediately inform the Supervisory Authorities and ask them to deal with them.

Violators will be punished according to the relevant provisions in the PRC Law of Advertisement and PRC Law on Medicine Administration. The authorities may order the violators to make corrections, suspend the adverts in question, forfeit advertisement agent fees and impose fines up to five times of the advertisement agent fees. For the advertising agents or publishers, they may even be disqualified to engage in advertisement business; for the advertisers, which are medicine manufacturers or distributors, their Medicine Manufacturing Permit or Distribution Permit may also be suspended in case of serious offenses.

Conclusions

Medicines directly relate to people's health and life. Inappropriate medicine adverts may mislead people into choosing the wrong medicine. Advertisements for medicines available over the counter play an especially big role in affecting people's choice of particular medicines. It is therefore appropriate and necessary to regulate medicine adverts and to impose severe penalties for breach of those.