The ARCSA has issued a new technical health regulation that replaces Ministerial Agreement No. 00385-2019 and its amendments. This regulation governs the obtaining of health registration, as well as the control and monitoring of biological products for human use.
Publication Date: January 21, 2025
Resolution: ARCSA-DE-2024-049-DASP
Key Points of the New Regulation
1. Legal and Technical Requirements
This regulation establishes the legal and technical requirements to ensure the quality, safety, and efficacy of biological products, under which the health registration certificate (for registration, modification, and re-registration) will be granted.
2. Exclusions
The following are not regulated:
Allergenic products prepared based on an individualized prescription.
Advanced therapy products of industrial manufacture.
Products under investigation.
3. Reasons for Application Denial
Applications for health registration may be rejected if:
Therapeutic efficacy is insufficiently justified.
Submitted documentation is incorrect or incomplete.
The product’s benefit-risk ratio is unfavorable.
New Features Introduced
1. Requirements for Advanced Therapy Medications
Includes products such as:
Gene therapy.
Somatic cell therapy.
Tissue engineering.
Advanced therapy medications with medical devices.
2. Conditions for Biosimilar Products
Must be approved by a WHO-recognized authority or the WHO Prequalification of Medicines Program (PQP).
Must have at least one year of commercialization in a country with a recognized authority, except for cases authorized by the National Health Authority.
3. Digital Leaflet
Products must include a link code on their external label that redirects to a website designated by ARCSA with updated product information.
This code must be available before commercialization.
4. Submission of Final Labels
The health registration holder must submit final labels, including the health registration number and link code, within a maximum of one year after obtaining registration.
Control and Monitoring
1. Production or Import Schedule
Holders must submit a tentative production or import schedule by the last business day of October each year.
2. Post-registration Controls
These will follow ARCSA’s annual plan and include two levels:
Type 1: Visual verification of labels and leaflets.
Type 2: Sampling for quality analysis.
3. Causes for Cancellation of Health Registration
The grounds for canceling health registration have been expanded to include:
Product quality failures.
Non-compliance with post-registration controls.
Lack of commercialization for over a year.
Commercialization without a batch release certificate.
Effective Date
The new regulation will come into force on June 20, 2025, six months after its issuance. For more information, please contact us. We will be happy to assist you.
Comments