In a recent development for the pharmaceutical industry in Peru, the regulatory authority, DIGEMID, has issued Notice "COMUNICADO N° 027-2024," signaling its readiness to accept applications for orphan drug approvals under Law 31738. This announcement comes even though the detailed regulation for the law is still pending approval. The move showcases the proactive approach of the Peruvian Ministry of Health in advancing the implementation of crucial regulations, even in the absence of finalized guidelines.
Understanding the Process
DIGEMID's notice outlines the application process for orphan drug approvals, emphasizing that the standard VUCE platform will not be utilized at this stage due to the ongoing review of the detailed regulation. Although specific content requirements for the application are not provided in the notice, DIGEMID has made the relevant application forms available on its webpage. Applicants are expected to submit key documentation, including a copy of the approval issued by the reference country's regulatory authority and Modules 2, 4, and 5 of the dossiers approved by the reference authority.
Potential Risks and Considerations
It is important to note that since the final regulation is not yet in place, there is a level of uncertainty surrounding the approval process. There remains a possibility that the regulatory authority may revise the procedure in the future, leading to potential modifications or adjustments required for approvals obtained through this interim pathway. Therefore, stakeholders navigating the orphan drug approval process must remain vigilant and adaptive to any forthcoming changes.
Moving Forward
Despite the evolving nature of the regulatory landscape, applicants and industry stakeholders can actively engage with the current process by diligently following the guidelines provided by DIGEMID. Ensuring that all required documentation is complete and in compliance with the outlined criteria will be key to a successful application submission. Moreover, staying informed and prepared to pivot in response to regulatory updates will be crucial for navigating the dynamic environment of orphan drug approvals in Peru.
Conclusion
The willingness of DIGEMID to accept applications for orphan drug approvals under Law 31738 before the final regulation is in place demonstrates a commitment to fostering innovation and addressing unmet medical needs in the country. While there are inherent risks associated with the interim process, proactive engagement and adherence to the current guidelines can pave the way for successful approvals in the evolving landscape of Peruvian pharmaceutical regulations.
DIGEMID's communication can be found below.
Stay tuned for further updates and insights on the shifting regulatory framework for orphan drug approvals in Peru.
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