Tagged with B

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA), a decentralized Health Ministry (HM) agency, is responsible for applying and enforcing the regulatory framework regarding human medicines, biologicals, and medical devices.  …

Pharma Legal Handbook As a general introduction, clinical trials are regulated in Ecuador via the Ministerial Agreement (MA) 0075-2017 and reform 0006-2020, which relates to regulations for approving, developing, monitoring, and controlling clinical trials. This regulation was enacted on June 30th, 2017. Other rules and regulations make MA 0075-2017 enforceable. The Constitution of…

Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process for marketing new drugs, biologics, medical devices, OTC, and other medicinal products is through a marketing authorization as detailed in question 3 of Chapter 1.  …

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The General Health Law (HL) and its regulations govern traditional, complementary, and alternative medicines. These medicines are known as natural, whose active ingredients are formed by any part of natural medicinal resources or combinations thereof,…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? In general terms, liability arises from the Civil and Criminal Codes, and it is personal responsibility for actions or omissions. However, the Consumer Protection Law establishes that civil damages may be claimed in case of damages caused by a defective…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? Any sign distinguishing goods and services on the market shall constitute a mark. Signs capable of graphic representation shall be eligible for registration as a mark; in particular, the shape of a product, its packaging, or wrapping may…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? Since former president Lenin Moreno vetoed the Health Code bill (September 2020), no developments have occurred.   2. When are they likely to come into force? Uncertain.

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? On September 17, 2019, Congress approved a reform of the Criminal Code, which reforms included the decriminalization of possession of drugs that contain cannabis or derivatives as their active ingredient for therapeutic, palliative, or medicinal use or the practice of…

Pharma Legal Handbook 1. What is the definition of Rare Diseases in your country? Our law states a specific definition for rare diseases, which is the following: They are mainly considered life-threatening or debilitating in the long term. They have low prevalence and high complexity and constitute many diseases. They are characterized by…

Pharma Legal Handbook 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? New productive investments made from January 2022, including those in the pharmaceutical sector, may be eligible for tax benefits. Investors generally benefit from a 3-point…

Global In conversation at ESMO 2024 in Barcelona, Astellas Chief Medical Officer Tadaaki Taniguchi lays out some of the company’s most promising recent oncology data, his hopes around how Astellas’ modality-based strategy will ultimately bring “meaningfully differentiated” therapies to patients, and why next-generation treatments stand to reshape the cancer care paradigm.…

France In conversation at ESMO 2024, Pierre Fabre’s R&D Head Francesco Hofmann outlines some of the key data readouts for the company’s oncology portfolio from this year’s conference, how it is looking to expand its R&D portfolio via business development deals and biotech partnerships, and the spaces in which a mid-sized…