再生醫療製劑組織及細胞招募廣告刊播辦法

The Regulations are prescribed in accordance with Paragraph 6 of Article 15 of the Regenerative Medicinal Products Act (hereinafter referred to as “the Act”).

1Before pharmaceutical firms publish recruitment advertisements for regenerative medicinal tissue and cell providers (hereinafter referred to as “recruitment advertisements”), the holder of the drug license or conditional authorization shall complete an application form and submit the following documents and materials, pay the review fee, and file the application with the central competent authority or its mandated or commissioned authority (agency) or juridical person (hereinafter referred to as “the reviewing authority”) in accordance with Paragraph 2 of Article 15 of the Act:

21. A photocopy of the drug license or conditional authorization.

32. Labels and package inserts.

43. Draft content of the recruitment advertisement.

54. Publication method plan.

65. Documents and papers required by the central competent authority.

1The contents of the recruitment advertisement shall include the following:

21. The name and address of the drug license or conditional authorization holder.

32. The name and address of the medical care institutions collecting the tissue and cells.

43. The qualifications of recruitment targets.

54. The types of tissue and cells to be collected and the product names of the preparations to be manufactured from them.

65. The method of tissue and cell collection.

76. Contact person and contact information.

87. The approval number for publication.

1The text, language, images, visuals, or other content of recruitment advertisements shall not contain the following:

21. Claims or implications that the acquisition or provision of tissue and cells is harmless to the health of providers.

32. Exaggeration of the benefits that providers may obtain.

43. Any representations containing coercion, enticement, or encouragement.

54. Expressions that disparage competitors’ technology, equipment, or business reputation.

65. Content that violates public order or good morals.

1Recruitment advertisements shall not be published through the following methods:

21. Publication or posting in the media, on job-matching websites, or on social networking sites, intended for sharing job information.

32. Publicity through interviews, news reports, introductions, or under borrowed names of others.

43. Publicity through coercion, enticement, or other improper means.

1Recruitment advertisements shall not be published at the following locations or sites:

21. Child care institutions.

32. Welfare institutes for children and youth.

43. Campuses of senior secondary schools and below, and early childhood education and care service institutions.

54. Other locations designated by the central competent authority.

1Upon approval of the application submitted under Article 2, the central competent authority, or its mandated or commissioned authority (agency), or juridical person shall issue an approval document for the publication of the recruitment advertisement. The approval validity period shall be no more than one year and shall not exceed the validity period of the license or conditional authorization.

2If continued publication is required after the expiration of the period specified in the preceding paragraph, an application for extension shall be filed within three months prior to expiration. Each extension period shall apply the provisions of the preceding paragraph mutatis mutandis.

The Regulations shall come into effect on the day when the Act becomes effective.