Month: November 2020

Cannabis Legalization in Brazil

With a growing demand for regularization and availability in the Brazilian market of various products obtained from the Cannabis sativa plant and because there is not enough data to prove the safety, efficacy and quality of most of the products obtained from this plant, the National Health Surveillance Agency ( ANVISA) started to create regulatory paths to make cannabis products available in Brazil.

As Cannabis products do not fit into any of the categories provided for in Brazilian health legislation, a new regulatory category was created, where the requirements for authorization, manufacture, import, dispensation, control, among others for Cannabis products were established.

The Sanitary Authorization for Cannabis products was created in order to make available, in the quickest way to the Brazilian population, safe and quality products containing Cannabis derivatives, but which did not complete the necessary studies for registration as a medicine.

The manufacturer or importer that wishes to commercialize Cannabis products must, prior to requesting Sanitary Authorization, have municipal and federal health licenses for the activities of manufacturing or importing medications and medications subject to special control. Federal health licenses are issued by ANVISA, and are called “Authorization of Business Operation – AFE” and “Special Authorization – AE”, for drugs subject to special control. In addition, it is necessary that the national or international manufacturer company has the Certificate of Good Manufacturing Practices for medicines issued by ANVISA and that it complies with the Good Distribution and Storage Practices of medicines.

To request Sanitary Authorization of Cannabis products, technical and scientific documents must also be sent to ANVISA containing the justifications, technically based, regarding the development of the Cannabis product, in addition to other documents and information, such as the labelling and packaging model, information leaflet, stability studies, among others.

It is important to note that Cannabis products can only be approved for use orally or nasal, in forms of immediate release and that the asset consists of plant derivatives or phytopharmaceuticals. In addition, Cannabis products are not allowed to be marketed in the form of a plant drug from the Cannabis spp plant. or its parts. In addition, cosmetics, smoke, health products and food will not be considered cannabis products, regardless of their status in the country of origin, when it comes to imported products.

Finally, it is important to clarify that the rule dealing with Sanitary Authorization for Cannabis products is temporary and will be revised in 3 years, which means that companies that are interested in obtaining authorization, have until December 2022 to adapt and request the granting of this authorization.

Technology: Imperative for Life Sciences

Throughout life sciences sector a certain viewpoint towards information technology has prevailed over the years. Unfortunately, too many life sciences organisations believe that technology doesn’t give their business any competitive advantages but only the most basic capabilities and therefore, they have traditionally minimised their investment in this area while still managing to maintain an appropriate performance level.

If life science companies want to lead their sector, they must quickly adopt the latest technologies so that they can progress and develop in the modern world in which we live today. Enterprises that are keen to lead the way in the life sciences sector must have a very clear strategy for the adoption of technology to achieve optimal success in the field.

The pressure on the healthcare sector to improve and evolve is massive. Technology will be the key to unlock immense value or the barrier that holds it back. For the companies that will lead the pack in the future, the technology overhaul is already under way.

Digital transformation offers biopharma and medtech companies opportunities to execute efficiently, engage effectively, and innovate new products and services. Technology allows patients to become more engaged with the care that they receive and they expect transparency and greater convenience in the health care services they benefit from.

Digital transformation initiatives will allow life science and healthcare brands to grow customer reach, improve overall user experience and boost customer retention by establishing a greater presence in the digital market. This means building a relationship with consumers through the personalization and customization of digital channels, as well as through selling products and services both directly and in digital marketplaces. These advantages will also extend to B2B sales opportunities within the life sciences field, further enhancing the overall digital brand.

Therefore, it’s imperative that businesses are able to innovate and adapt in the ever-changing life sciences market.