How to Simplify the Product Registration Process with ANVISA?

ANVISA offers mechanisms to simplify registration in specific cases, such as “clone” drugs, products identical to others already registered, except for name, labeling, or intended use. According to RDC 954/2024, companies in the same economic group or partners in Productive Development Partnerships (PDP) can use this resource to reduce deadlines by up to 60%.

Essential eligibility criteria:

• The “parent” product must have a valid registration and comply with technical standards;
• It cannot have had its renewal denied due to quality, safety, or efficacy failures;
• It must be included in ANVISA's list of reference drugs or be therapeutically equivalent to one of them.

Practical advantage: Companies that use simplified registration avoid repeating clinical and technical studies, reducing costs by up to 40%.

REGISTER YOUR PRODUCT WITHOUT BUREAUCRACY

Since 2025, ANVISA has intensified its digital transformation, requiring all requests to be made via platforms such as Sistema Solicita and SEI. These systems streamline analyses, but errors in filling out forms are the main cause of rejection.

Steps to avoid mistakes:

• Validate documents before submission: Ensure that good practice manuals, stability studies, and labeling are in line with RDC 47/2009;
• Use official checklists: ANVISA provides checklists by product type;
• Follow up in real time: Monitor progress via Document Status Inquiry to respond to requirements quickly.

Crucial fact: 30% of cases are shelved due to inconsistencies in documents or response times.

1. Incomplete documentation
   Lack of stability studies or technical reports results in summary rejection. Solution: Conduct preliminary audits with specialists.
2. Non-compliance with good practices
   Companies without an Operating Permit (AFE) or Good Manufacturing Practices Certificate (CBPF) cannot register products. Solution: Get in compliance before filing applications.
3. Classification errors
   Using the wrong subject code (e.g., confusing “similar drug” with “generic”) stalls processes. Solution: Consult the code guide on the ANVISA portal.
4. Inadequate communication
   Failure to respond to requests within 30 days leads to filing. Solution: Designate someone to monitor notifications.
5. Ignoring post-registration
   Changes to approved products require a new application. Solution: For minor changes, use the simplified post-registration procedure.

REGISTER MY PRODUCT WITH STRATEGY

Mastering ANVISA regulations requires not only technical knowledge, but also practical experience in process management, which is where Stone Okamont acts as a strategic extension of your team.

With Stone Okamont, you can turn regulatory requirements into growth opportunities. Request an assessment and find out how our experts can streamline your registration.