ANVISA published a new resolution RDC 954/2024 that establishes criteria for the simplified procedure for registration, post-registration and renewal of generic, similar, specific, dynamized, herbal medicines, radiopharmaceuticals and biological products. This change promises to streamline processes, but it also requires extra attention from pharmaceutical companies to adapt to the new rules.
The simplified procedure is a more agile way to register, renew or make post-registration changes of medicines. It allows companies to link new petitions to an already registered drug (called a “primary matrix petition”), as long as they meet specific criteria, such as therapeutic equivalence and compliance with ANVISA standards.
With this, companies can obtain benefits such as:
- Reduction of time and bureaucracy in the registration of new medicines.
- Facilitation of processes for companies of the same economic group or involved in Productive Development Partnerships (PDP).
- Increased predictability for post-registration changes and registration renewals.
Scope of legislation
The resolution directly impacts:
- Pharmaceutical companies that produce or import generic, similar, specific, dynamized, herbal medicines, radiopharmaceuticals and biological products.
- Economic groups that have already registered medicines and wish to link new petitions to these registries.
- Productive Development Partnerships (PDP) and companies involved in technology transfer.
Despite being very comprehensive, there are still some restrictions such as for radiopharmaceuticals registered under RDC No. 263/2019, companies that do not have an operating authorization (AFE) compatible with the requested registration and petitions that do not meet the requirements of the Therapeutic equivalence criteria or not are linked to a valid primary petition matrix.
Major Changes in the Resolution
Electronic Petitioning: All petitions must be made exclusively electronically, using the FP1 and FP2 forms available on the ANVISA portal. In exceptional cases of unavailability of the system, physical petitioning will be allowed.
Required Documentation:
– Completed and signed FP1 and FP2 forms.
– Technical justification for the choice of the mother petition.
– Declaration of link to the mother petition.
– Updated labeling and package insert templates.
Post-Registration Renewal and Changes: Post-registration changes must be replicated in the simplified petition within 30 days of filing in the parent petition and registration renewal must be requested in advance, accompanied by proof of commercialization.
Disconnection of Processes: In specific cases, such as completion of technology transfer or rejection of the renewal of the parent petition, the processes can be unlinked and proceed independently.
How to adapt to the New Resolution?
Update yourself: Know all the details of the Resolution and check if your medicines fit the criteria for the simplified procedure, do internal training on the subject so that the new information is incorporated into the company’s daily life.
Prepare the Documentation: Good preparation with the regulatory affairs team is indispensable, ensure that all necessary documents, such as FP1 and FP2 forms, bond statements, and technical justifications, are complete and up to date.
Invest in Technology: Use document management and electronic petitioning systems to streamline processes and avoid errors, but don’t forget that for this, it is always necessary to maintain the validated status of your system.
Monitor Deadlines: Pay attention to deadlines for post-registration changes, renewal, and unlinking processes. Failure to comply may result in cancellation of registration.
Consult Experts: If in doubt, seek guidance from consultancies specializing in health regulations to ensure compliance with the new rules.
ANVISA’s new resolution brings opportunities to speed up the registration and renewal of medicines but also requires attention to the new rules and deadlines. Companies that prepare properly will be able to enjoy the benefits of the simplified procedure, while those that do not comply may face deregistration and sanctions.
