Brazilian Health Regulatory Agency (Anvisa) has recently published a regulatory framework for the medicinal gases sector. The Collegiate Board Resolution (RDC) 870/2024 and the Normative Instruction (IN) 301/2024 aim to enhance technical requirements and ensure the safety, efficacy, and quality of these essential health products. Below, we detail the key points of this new regulation, which will take effect on July 1, 2024.
Key Aspects of the New Regulation
RDC 870/2024 : RDC 870/2024 sets the minimum requirements for the notification, registration, and post-registration changes of medicinal gases classified as medicines. This regulation is crucial for ensuring that all products on the market meet rigorous quality and safety standards. Companies will have 24 months to comply with the new rules.
IN 301/2024 : IN 301/2024 complements RDC 870/2024 by defining the list of medicinal gases subject to notification. This list helps Anvisa map out in detail which gases are being produced and marketed, as well as the production locations, facilitating sanitary surveillance.
Scope and Exclusions
It is important to note that the regulations apply exclusively to medicinal gases classified as medicines. Gases used in health that do not fall into this category are not within the scope of these regulations. For specific clarifications, Anvisa provides Technical Note 34/2020.
Objectives of the New Regulatory Framework
Ensuring Quality and Safety: The registration and notification of medicinal gases will allow for rigorous control over the production and marketing of these products. Anvisa can ensure that only safe and effective products reach the market, adhering to defined quality standards.
Facilitating Sanitary Surveillance: With more detailed control, Anvisa can perform more efficient sanitary surveillance actions, such as monitoring the availability of medicinal gases in the health system, thus ensuring supply continuity and patient safety.
Development of the Regulations
The creation of these regulations involved a long and transparent regulatory process, with interactions with foreign regulatory authorities, the regulated sector, the Brazilian Pharmacopoeia, and related technical areas. This dialogue was crucial for developing robust regulations aligned with international best practices.
Understanding Medicinal Gases
The regulated medicinal gases include products in the form of compressed gas, liquefied gas, or cryogenic liquid, either alone or in combination. They are used in various medical fields, including:
- Anesthesia and analgesia: Nitrous oxide.
- Inhalation therapy: Oxygen.
- Pulmonary hypertension treatment: Nitric oxide.
- Surgical procedures: Nitrous oxide and carbon dioxide.
Benefits of the New Regulation
- Improved product quality: The new rules ensure that all medicinal gases meet rigorous standards.
- Increased transparency: With notification and registration, Anvisa will have a complete overview of the production and marketing of medicinal gases.
- Safety for the population: The regulation ensures that only effective and safe products will be available on the market.
For more information, consult Technical Note 34/2020 or visit Anvisa’s website.