Life Sciences Newsletter – April 2025

LIFE SCIENCES NEWSLETTER

RARE OR ORPHAN DISEASES (RHD) AND ONCOLOGICAL DISEASES

Requirements for the accelerated procedure of sanitary registration

Supreme Decree 004-2025-SA was published, which regulates the provisions of Article 9 of Law 29698, Law that declares of national and preferential interest the care and treatment of persons suffering from rare or orphan diseases, as amended by Law 31738.

It establishes the requirements to obtain and maintain the sanitary registration of pharmaceutical products that have an enabling title in countries with high sanitary vigilance, destined to the integral attention, including diagnosis and treatment of rare or orphan diseases, or destined to oncological treatments.

This Supreme Decree will enter into force on October 13, 2025.

MODIFICATION OF THE APPROVAL FORM FOR INFANT FOOD

Modification of the approval form for infant food with milk and cereals.

Ministerial Resolution 245-2025/MINSA approved the modification of the Approval Form for “Instant, fortified, powdered baby food with milk and cereals”.

It establishes the requirements that the fortified food must meet for contracts with the State.

DIGEMID

GMP Certification in Colombia, India and Mexico.

By means of Ministerial Resolutions 223, 225, 279, 280, 281-2025/MINSA, Digemid officials were authorized to travel to carry out inspections to laboratories in Colombia, India and Mexico in order to grant GMP certification.

BILLS

The elimination of the DIGEMID is proposed.

Bill 10902/2024-PE proposes the creation of the National Authority of Pharmaceuticals, Medical Devices and Health Products – APEMED.

• APEMED will be a Specialized Technical Public Body attached to MINSA, just like INS and SUSALUD. This implies that it will have functional, administrative, technical, economic and financial autonomy.
• APEMED will be able to regulate and control the following activities related to pharmaceutical products, medical devices, sanitary products and the materials used in their manufacture: research, manufacture, import, export, storage, distribution, commercialization, promotion, advertising, dispensation, sale, use, donation and final destination.
• APEMED will have competence over preclinical and clinical research on investigational products for human use. DIGEMID and the Clinical Trials Sub-Directorate of DIIS-INS will transfer their functions to APEMED.
• APEMED will have a Disputes Tribunal, which guarantees that challenges to administrative acts will be reviewed by a technical and impartial body.
• The executive president of APEMED and the members of the APEMED Disputes Tribunal will be elected by public competition.

Phasing out benzoyl peroxide in topical uses.

Bill 10808/2024-CR proposes to prohibit the use of benzoyl peroxide in the manufacture and commercialization of topical products in the country.

It is proposed to give a term of 6 months for the pharmaceutical and cosmetic industry to replace this component in products for topical use.

DRAFT SANITARY STANDARD

Requirements for transporting foodstuffs

Ministerial Resolution 229-2025-MINSA published the draft of the Sanitary Standard for those who transport food, whether to distribute, market, store, provide collective food services, manufacture, fractionate or deliver.

This normative document establishes the Sanitary Surveillance and Good Handling Practices in Food Transportation.

DIGESA received comments on the draft until April 17, 2025.