Life Sciences Newsletter No.8 – November 2021

Our Public and Regulatory Law team presents the eighth edition of the Life Sciences Newsletter, with a compilation of the main news and information of the area occurred in November.

Demarest’s Public and Regulatory Law team continues to monitor developments in the Life Sciences area, and is available to provide any clarification or further information on these and other topics.

Happy reading!

Read the seventh issue here.

ANVISA – National Health Surveillance Agency

Get to know the Brazilian Pharmacopoeia Five-Year Plan

On November 3, 2021, the Brazilian Health Regulatory Agency (ANVISA) made available its Five-Year Strategic Plan for Brazilian Pharmacopoeia, which establishes strategic objectives for the official pharmaceutical code. The Plan seeks to improve Pharmacopoeia’s governance practices, modernize it based on sustainability principles and improve its performance in international regulation and health control in the country. The collegiate bodies of Pharmacopoeia were once again instituted by means of the Resolution of the Collegiate Board of ANVISA (RDC No. 467/2021).

Among the topics listed for discussion and development until 2026, it is worth highlighting the inclusion of molecular markers for identification tests of plant-based drugs, that is, medicinal plants, which signals an important step taken by Pharmacopoeia on the subject.

ANVISA – National Health Surveillance Agency

ANVISA approves two new Cannabis-based products

Resolution RE No. 4,134, of October 29, 2021, published on November 4 of this year, revises the list of cannabis-based products approved by the Agency, now totaling seven products. These include plant extracts (cannabis sativa zion medpharma 200 mg/ml extract and cannabis sativa promediol extract), obtained in a different way from the five already registered (only with cannabidiol).

The Resolution contains an attachment that specifies the characteristics of the approved products and can be accessed through the : https://www.in.gov.br/en/web/dou/-/resolucao-re-n-4.134- de-29-de-october-de-2021-356925848. This means greater regulation of these products in the sector and a step forward in scientific research related to the subject, which is as complex as it is controversial. For more information about this subjectand relevant developments on the topic, check out our Newsletter No. 1, No. 2, No. 3, No. 5 and No. 7.

ANVISA – National Health Surveillance Agency

Resolution expands the authorization of clinical trials with drugs in Brazil

On November 4, 2021, ANVISA published Resolution of the Collegiate Board of Directors RDC 573/2021, which urgently and temporarily amends Resolution RDC No. 9 of 2015, which approves the regulation for conducting clinical trials with medicines in Brazil. The measure comes in order to speed up the bureaucratic process as a result of the state of emergency caused by the Covid-19 pandemic.

The new Resolution was designed to reduce the time taken for ANVISA’s approval and authorization of clinical research. It authorizes the entry of research carried out by at least one regulatory authority from at least one founding or permanent member country of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) or the regulatory authority of the United Kingdom (MHRA).

The Resolution’s validity will expire after 120 days (from the date of its publication), allowing time for the Ministry of Health to announce the end of the state of emergency that was declared in response to the virus.

ANVISA – National Health Surveillance Agency

ANVISA speeds up the import of Cannabis-based products

On November 17, 2021, ANVISA published Resolution RDC No. 570/2021, simplifying the criteria and procedures for importing Cannabis-based products by natural persons. According to the new regulation, patients will have registration approval with simplified analysis in the case of cannabis-based products contained in a technical note issued by ANVISA’s Controlled Products Management and published on the Agency’s website, now occurring automatically, following the system’s update.

The Resolution reduces waiting times and makes the process of importing cannabis-based products simpler and more efficient. Through such process, the queue time for obtaining these products will be reduced by 85%, according to the regulatory agency.

ANVISA – National Health Surveillance Agency

ANVISA announces end of temporary law on the import of medicines and medical devices

On November 18, 2021, ANVISA repealed , Resolution of the Collegiate Board No. 483/2021, which established, in an extraordinary and temporary manner, the requirements for the import of new medical devices and drugs identified as priority for use in services due to the international public health emergency related to SARS-CoV-2.

With the increase in vaccination in the country and the consequent decline of the virus as well as occupancy in the hospitals, the Agency understood that the extension of the Resolution is no longer necessary, since the demand for the consumption of medicines and health products in Brazil is no longer a major concern for specialists.

ANVISA – National Health Surveillance Agency

Senate approves monitoring of medicine quality

On November 16, 2021, the Brazilian Senate approved Bill No. 589/2021, which aims to amend Law No. 6.360/1976, to provide for the quality control of medicines in the post-marketing period, and Law No. 9787/1999, to make it mandatory that drug bioequivalence studies be carried out in laboratories authorized for this purpose.

The plenary of the Brazilian Senate decided that quality control and inspection of the effectiveness of medications should be more rigorous, with an assessment of adverse events, quality deviations and any aspects that may affect their therapeutic effectiveness. The Bill now goes to the House of Representatives, which will also discuss the issue and may vote for its approval.