June 18, 2019
The Brazilian FDA published the Notice for Public Comments 654 and 655, of June 13, 2019, to establish the regulation of registration of medicinal products based on Cannabis spp, and its derivatives and synthetic analogues technical, as well as the administrative requirements for its cultivation for medicinal and scientific purposes. The Public Consultation was approved during the 14th DICOL Meeting held on June 11, 2019
Unanimously approved, the Notice for Public Comments are opened for 60 days. During this period, it is expected that the agency will promote Public Hearings and issue guides, manuals and training to detail the requirements in the regulatory proposals, and to promote effective public participation.
The first proposal related to the regulation of requirements for the registration and monitoring of Cannabis-based medicines in Brazil, as well as their synthetic derivatives and analogues, aims to improve the population’s access to such medicines because the access through imports is deficient due to price and bureaucracy, and does not have the necessary pharmacovigilance and quality monitoring.
The regulation is limited to oral administration products for the treatment of serious debilitating or life- threatening diseases without any other therapeutic alternative.
If there is interest in the production and marketing of these drugs in the Brazilian market, it’s necessary to submit a data package to the Brazilian FDA, which will assess the proof of the drug’s quality, safety and efficacy, and the compliance with Good Pharmaceutical Practice principles. The approval will be valid for 3 years.
The request for approval may be made in the CTD format, and must present the description of the disease, the relevance of the drug and the proof of safety in its administration and, in case of the drug being registered in other countries, the technical report issued by the regulatory authorities. The long-term stability studies presented may be ongoing, and safety and efficacy reports may present Phase II studies completed or Phase III ongoing, provided its feasible.
The documents submitted could be complemented after the granting of the approval by signing a Term of Commitment between the Brazilian FDA and the legal entity.
Also, the renewal is subject to clinical study and substitute report related to benefits and risks and can have the deadline established in according to the pertinent legislation about the category of the drug.
Brazilian FDA will monitor pursuant to the pharmacovigilance regulations, through the national drug control system, and it is mandatory to submit, at the time of registration, the risk minimization plan.
Finally, the legal entity must submit the maximum price definition data package within 30 days of the approval request, and the registered drugs should begin to be marketed within 365 days of the published approval date, to avoid delaying records.
The second proposal, which deals with the technical and administrative requirements for cultivating the Cannabis plant for medical and scientific purposes, aims to regulate the theme to ensure scientific progress and greater control of quality and safety of Cannabis-based drug production in Brazil.
The intended regulation covers obtaining the seed for planting, to the stage of drying and stabilization of the plant, and requires the cultivation only by a legal entity, in a closed environment, limiting the sale to research institutions and manufacturers of pharmaceutical or drugs, excluding galenic pharmacy.
Brazilian FDA’s Special Authorization for cultivation will be necessary, which will be granted through inspection that will evaluate the site and its environmental protection applied, general location and worker safety, fault identification system and corrective measures, and the legal entity partners check of criminal records.
As security and monitoring requirements, the proposal aims to establish that the place of cultivation or storage is unidentified, with access blocked by biometric recognition and determinations about the doors, windows and ducts, alarm and video systems, as well as independent electricity generators.
The research development should be subject to a Special Authorization for Research Cultivation (CPA), valid for 2 years, and it will be necessary to send quarterly and annual reports about the research, which should be specific and with a determinate scope.
In both cases, the company will be responsible for the destruction of the waste by composting, packaging, transport and incidents, which must be reported to the authorities immediately, and investigated within 5 days.
The Brazilian FDA’s control will be carried out by means of criteria for cultivation quota, bookkeeping, inventory control and product release by computerized system.
All these requirements will be subject to notice for public comments and the resolutions still depend on Brazilian FDA’s approval.
We remain at your disposal should you require further information on the topic.