novas regras_interna 12015 began with the publication of new rules in healthcare area that will contribute to the emergence of opportunities for industries in the sector and in the country as a whole.

The enactment of Law No. 13,097, on January 19th, 2015, has brought more flexibility to ANVISA’s actions, so that these actions are directed to situations of greater impact on society, ultimately allowing the development of the healthcare sector, as for example, in cases of clinical trials. Another advantage brought by this new law to the healthcare industries is related to the validity term of healthcare products’ registration under ANVISA’s surveillance. In fact, the referred law makes it possible to extend the validity term from 5 to 10 years, considering the product’s nature and the sanitary risks involved in its use. Furthermore, Law No. 13,097, establishes that the industries in the sector are exempted from payment of renewal fees.

Finally, for the purposes of supervision and monitoring of products subject to Health Surveillance system, the referred law also foresees the use of sanitary inspection reports by agencies or international institutions accredited by ANVISA.

Furthermore, ANVISA published Resolution RDC No. 09, on February 20, 2015, establishing new rules for the development of clinical trial of medicinal product in Brazil. This resolution defines the maximum period of 30 days for ANVISA to assess the Clinical Development of the Medicinal Product Report (DDCM) prepared by the company that either owns the drug or by the clinical agency doing the testing. Where ANVISA does not manifest in time, the clinical trial can be conducted, as long as it is approved on the ethical aspects of the research. However, regarding experimental drugs, in order to be allowed to proceed to Phase I and Phase II, as well for clinical development of biological products, the previous approval of ANVISA is still necessary. Clinical researches in the examination phase III, to be held simultaneously in different countries, will also benefit from this new rule.

The new rule also provides a type of approval that concentrates all phases of clinical studies into one single analysis, in order to harmonize national legislation on the subject with other international regulatory bodies.


About the authors

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Biominas Brasil is a private institution, established in 1990, dedicated to creating companies and businesses in the life sciences industry in Brazil. Biominas supports national and international research projects, companies and investors in all stages of development, through a variety of services including Consulting, Business Development and Incubation. Biominas also publishes studies and organizes business events for the life sciences sector, such as BIO Latin America. Learn more at

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The law firm Di Blasi, Parente & Associates has as its primary mission the legal management and advisory services to individuals and businesses possessing intellectual property creations and technological developments, especially in cases that they want to use their intellectual assets for investment and business expansion. The firm operates in the areas of intellectual property, business law, regulatory law, antitrust law, unfair competition law, franchising, consumer law and corporate law, including tax and foreign exchange sectors. Learn more at