The National Agency for Health Regulation, Control and Surveillance (ARCSA), Dr. Leopoldo Izquieta Pérez, has issued the Technical Sanitary Regulation for the oversight and control of advertising and promotion of pharmaceutical drugs, processed natural products for medicinal use, homeopathic drugs or products, and medical devices.
The regulation establishes a legal framework for advertising and promotion of drugs, processed natural products for medicinal use, homeopathic products or medications, and medical devices.
Under this regulation, drug advertising will not require prior approval from the authority, but must comply with the legal framework, as well as with the conditions approved in the health registry. To verify compliance, ARCSA will carry out subsequent controls.
The following will be considered forms of advertising at points of sale:
- Packaging that includes additional quantities of the same product.
- Discount coupons or messages such as “savings” when featured directly on the product’s packaging.
- Advertising displayed through digital media, websites, or social networks, including promotional offers or marketing content.
In addition, regulation specifies that when third parties advertise drugs, they must have a contract with the registration holder. Otherwise, third parties will be liable to the authority for any non-compliance.
The regulation also stipulates that pharmaceutical establishments are strictly prohibited from offering incentives to healthcare professionals.
The technical regulation will come into force on July 23, 2025.
Technical and Sanitary Regulation for Obtaining the Health Registration, Control, and Surveillance of Biological Products for Human Use
The National Agency for Health Regulation, Control and Surveillance (ARCSA), Dr. Leopoldo Izquieta Pérez, has issued the Technical and Sanitary Regulation for Obtaining the Health Registration, Control, and Surveillance of Biological Products for Human Use.
The new technical regulation stipulates a legal framework to ensure the quality, safety, and efficacy required for granting health registration certificates for biological products. The following products will not be classified as biological products for human use:
- Allergenic products prepared based on an individualized prescription;
- Advanced therapy products of non-industrial manufacture; and,
- Products under investigation.
Within six months from the date this regulation comes into effect, those who have not obtained the release certificate for the first batch of products and are commercializing them in the country, must apply for the release certificate. After the granted period, ARCSA will initiate the corresponding administrative processes.
The technical regulation will come into force on June 21, 2025.
Technical sanitary regulation for health registration, control, and surveillance of general drugs for human use
The National Agency for Health Regulation, Control and Surveillance (ARCSA), Dr. Leopoldo Izquieta Pérez, has issued the Technical Sanitary Regulation for Health Registration, Control, and Surveillance of General Drugs for Human Use.
The new technical regulation stipulates that obtaining health registration for new drugs must adhere to the structure of the Common Technical Document (M4 CTD) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The document is organized into the following modules:
- Module 1: Administrative Information and Prescription Information
Legal, technical, and administrative information.
- Module 2: Summaries
Summaries of preclinical, clinical, and quality data.
- Module 3: Quality Information
Data on active ingredients, manufacturing, and product controls. - Module 4: Non-Clinical Study Reports
Non-clinical data such as pharmacological, toxicological, and safety studies conducted. - Module 5: Clinical Study Reports
Clinical data obtained from studies in humans, such as clinical trial reports, efficacy and safety data, and statistical analyses.
The authority will consider “new drugs” if its active ingredient is entering the country for the first time, including new combinations, new administration routes, new pharmaceutical forms, and concentrations of active ingredients outside the dosage ranges already registered locally or internationally by an authority recognized by the World Health Organization. Generic drugs will not be considered new medicines.
In this context, applicants seeking health registration for new medicines must submit the CTD format within six months from the date the regulation is published in the Official Bulletin.
Among other significant changes, the regulation stipulates that abbreviated chemical formulas must not be used on medicine labeling.
Furthermore, Article 71 states that if medicines remain unmarketed in the country for one year, their health registration will be suspended. However, this contradicts Article 12, which stipulates that in such cases, the health registration will be canceled.
Additionally, for medicines classified as “over-the-counter,” the physical patient information leaflet may be substituted with a digital version once ARCSA establishes the website serving as a repository for approved leaflets.
The technical regulation will come into force on June 30, 2025.
Ministerial Agreement No. 00069-2024 (Regulation for the Oversight of Clinical Trials with Medicinal Products and Processed Natural Products for Human Use)
The Ministry of Public Health issued Ministerial Agreement No. 00069-2024 (Regulation for the Oversight of Clinical Trials with Medicinal Products and Processed Natural Products for Human Use).
The regulation establishes a legal framework for the authorization and oversight of clinical trials conducted in Ecuador involving medicinal and processed natural products for human use.
Clinical trials must be approved by the Human Research Ethics Committee and authorized by ARCSA. According to the regulations, the research protocols that are currently being carried out in the country will not be authorized.
Regarding informed consent processes for trial participants, it must be ensured that this also applies to the future use of their biological material and data, as appropriate.
Furthermore, the regulation stipulates that the sponsor of the trial must inform ARCSA of any serious and unexpected adverse reactions that may be related to the products under investigation and that occur within or even outside the country.
The sponsor must have a legal representative domiciled in the country.
The technical regulation will come into force on December 31, 2024.
Felipe Samaniego, Partner at CorralRosales
felipe@corralrosales.com
+593 2 2567676
Verónica Manrique, Associate at CorralRosales
veronica@corralrosales.com
+593 4 2630441