RDC 749/2022 is the Resolution of the Collegiate Board, created by Anvisa to regulate the exemption of bioequivalence/bioavailability studies in producing new drugs — which is called biowaiver. After being published, this resolution led to the revocation of the former RDC 37/1 RDC 37/11.
The main objective of the new RDC is to ensure the interchangeability of generic medicines concerning reference products. In this way, the resolution helps to prove and compare the quality, efficacy and safety of this type of drug.
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What is an RDC
In Brazil, an RDC (Resolution of the Collegiate Board) is a type of rule created by the National Health Surveillance Agency (ANVISA). They regulate and guide companies (and other public agencies) on aspects that may affect public health.
The main resolutions address areas such as the control of medicines, food, cosmetics and health products. In this way, they establish standards, norms, guidelines and procedures that ensure the effectiveness of products and services that affect the health of the population – thus safeguarding its safety.
Because they are often linked to ever-changing areas, RDCs undergo many updates. Therefore, companies need to pay attention to these novelties to ensure compliance with Anvisa.
Learn more: What is RDC (Resolution of the Collegiate Board)?
What is RDC 749 2022
This resolution has the main practical objective of defining which drugs need studies that demonstrate their safety and efficacy before being approved; and which ones don’t. The RDC is focused on generic, similar, or even innovative products that use the comparability route as a strategy for approval.
According to the text of the RDC:
“This Resolution provides for the criteria for the exemption of relative bioavailability/bioequivalence studies. (…) This Resolution applies to generic, similar, new and innovative medicines. (…) The company interested in the exemption from the relative bioavailability/bioequivalence study must submit a specific report in the registration or post-registration petition, containing the technical rationale for the biowaiver based on the requirements outlined in this Resolution”.
As Brazil is a market that has been developing many studies of pharmaceutical equivalence and bioequivalence, RDC 749 arises to define the requirements for biowaiver.
With resolution 749, these criteria were updated based on the scientific knowledge currently available to favor international convergence.
As a result, RDC 749/2022 makes Brazilian legislation more robust. Thus, it ensures that generic/similar/innovative drugs are safe and effective compared to their respective reference drugs.
To achieve this goal, Anvisa requires that, before the registration of generic or biosimilar drugs, a bioequivalence study be carried out to compare them with the reference drug.
However, in the case of new and innovative medicines, some exceptions revoke the obligation of these studies. With RDC 749, the regulatory agency makes it clearer what these cases of biowaiver are. The main ones are:
- When the concentration at which in vivo bioequivalence has been demonstrated, in cases where the other proposed concentrations are within the approved therapeutic range. Remember that for this to happen, competent federal agencies must have evaluated and approved the safety and efficacy data.
- When there are post-registration changes in the biopharmaceutical classification system due to the pharmaceutical form, route of administration or site of action. Important: this does not apply to cases of changes related to dosage, expansion of use, the inclusion of a new route of administration, new therapeutic indication and the inclusion of a new concentration.
Even in the case of drugs that do not fit into either of these two situations, companies can still request biowaiver. For this, prior consultation and presentation of technical justification to the organizational unit responsible for this analysis is required.
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What is biowaiver?
According to Anvisa, biowaiver can be defined as analytical studies that aim to exempt drugs from classes I and III of the biopharmaceutical classification system from bioequivalence studies. This can occur through solubility analyses, dissolution profile in three media, pharmaceutical equivalence and comparative dissolution profile in three media.
In the context of RDC 749, the biowaiver covers the regulatory procedure that can allow the waiver of clinical studies of relative bioavailability/bioequivalence. As the Resolution highlights, biowaiver is very frequent in the registration of generic drugs, as it speeds up the approval process and ensures that the products are effective and safe, reaching the market quickly.
A biowaiver study is carried out by Fiocruz, and the service can be requested by citizens, companies, public agencies and entities and other segments. To have access to such a study, it is sufficient to make the samples available at the test site.
In general, this process occurs as follows:
- The customer requests the quote through the email sefar@fiocruz.br;
- The customer approves the budget and sends it signed to the same email above;
- The customer signs the Contract or Cooperation Agreement and sends it to Sefar;
- The customer sends the samples to SEFAR-EQF, which need to be delivered by qualified personnel. This step requires the letter of shipment of the samples;
- Finally, after the analysis, all service reports are delivered.
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Conclusion
As you have seen, RDC 749 2022 was created to make the drug market more up-to-date and efficient compared to what occurs in the rest of the world — especially concerning generics and the like.
However, the Resolution is based on various types of literature and practices already existing in other countries, so as not to lose sight of its main objective: to ensure the safety and efficacy of the medicines that are offered to the population.
In this way, updating the regulation provides companies with an opportunity to review and adapt processes. This can represent significant gains in their life cycles, maintaining safety and quality, within compliance with legislation.
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