Brazil is emerging as an attractive location for clinical research as it offers access to a range of patient demographics and medical facilities due to its diverse population and robust healthcare infrastructure. Conducting clinical trials for investigational products is a meticulous and highly regulated process, requiring sponsors to adhere to stringent guidelines. This ensures the safety, efficacy, and the ethical conduct of clinical trials. However, a robust and thorough knowledge base on regulations is needed to navigate the regulatory landscape for clinical trials. This includes protocol submission, ethics committee approval, and adherence to GCP standards.
In clinical research, an Investigational Product (IP) is the cornerstone upon which the safety and effectiveness of drug treatment are evaluated. In Brazil, an elaborate profile has actually been developed to explain clearly the various rules, procedures and quality standards that monitor the management, manufacturing, importation and handling of IPs. Regulatory frameworks from various sources such as manuals or legal provisions have also been used to distil information contained here about the multifaceted landscape surrounding IPs in clinical trials.
Defining an Investigational Product
According to PANDRH-GCPs, an Investigational Product (IP) can be defined as dosage forms of active ingredients or placebos being tested in clinical trials, or being used as a reference in a trial. However, according to Brazilian regulations as exemplified by ResNo9, G-BioIProdManual and G-SynthDrugProdManual an IP may also be an experimental drug, comparator or any other product being used in a trial. This difference in the definition because when ResNo9 was adopted, an IP was associated with imports that were needed to conduct clinical trials. According to the PANDRH-GCP, an IP can also include a product that has a marketing authorization when used/assembled in a different way from the “approved” form, or if it used to get more information about an “approved use”.
Manufacturing & Importation and Advanced Therapy products
ANVISA’s oversight extends to all stages of IPs, from production to importation. ServBltnNo104 introduces simplified review tools that speed up the process without compromise in quality and emphasizes compliance with ICH guidelines. ANVISA’s assessment is underpinned by extensive documentation such as stability tests and labeling instructions. ResNo172 importantly outlines procedures for importing IPs which stresses the need for strict conformity to storage, transportation, and ethical requirements.
Emerging trends in pharmaceutical research, such as advanced therapy products based on genes, tissues, or cells, warrant specialized regulatory frameworks. ANVISA’s initiatives, as outlined in BRA-86 and BRA-94, cater to the evolving landscape of advanced therapies, facilitating import license requests and ensuring timely review processes.
Quality Requirements and Product Management
Maintaining the highest standards of quality is paramount in IP management, these can be achieved by keeping track of following information-
- Investigator’s Brochure: Sponsors have to provide full information on experimental drugs, their formulation, pharmacology, safety profiles and clinical trial update.
- Quality Management: The production process of the investigational products has to meet the requirements of Good Manufacturing Practices (GMPs) as stipulated in ResNo301. To ensure that the product is safe and effective, there are strict quality control measures in place.
- Labeling: IP labeling has to follow stringent regulation for provision of clear and accurate data for study participants and stake holders. It includes such requirements as sponsor’s name, dosage details, batch number, expiry date as well as storage conditions – all in Portuguese.
Supply, Storage, and Handling: The success of IP depends on the efficiency of supply chain management which includes importation, distribution and storage. Strict adherence to GMP is guaranteed by subjecting each shipment through a system which must be recorded from its receipt until the final stage. Moreover, ANVISA’s membership in PIC/S is another proof that Brazilian regulatory authority is dedicated to maintaining globally agreed GMP norms.
Record Requirements: The trial lifecycle transparency and accountability are ensured by proper record keeping mechanisms established in line with PANDRH-GCPs. A sponsor is required to keep complete records of all the activities carried out on IP including shipment, receipt, and disposal. These documents also help in attesting to the soundness and honesty of how clinical trials are conducted.
Conclusion
the management of Investigational Products in clinical trials calls for coordinated interaction between regulatory oversight, quality assurance protocols and meticulous record-keeping systems. The significant role that ANVISA plays in ensuring adherence to international standards underlines Brazil’s commitment to developing a strong clinical research ecosystem that ultimately moves forward boundaries of medical science and innovation.
In addition to regulatory and pharmacovigilance services for global customers, DDReg Pharma also offers expert clinical regulatory services to support with the Clinical Trial Applications. Reach out to the experts for more information. Read more from the experts about clinical trials here: Assessing COVID-19 Symptoms in Clinical Trials