Approval of the “Guide for the Development of a Market Surveillance Program to Monitor the Quality of Products Regulated by the ANRS Throughout the Supply Chain”

Carlos Úbeda, lawyer in ARIAS Nicaragua and expert in Lifescience Law, shares the following news: On October 4, 2024, the National Health Regulation Authority (ANRS) of Nicaragua approved the "Guide for the development of a market surveillance program to monitor the quality of products regulated by the ANRS throughout the supply chain” through which are established the quality monitoring criteria for products regulated by the ANRS and the responsibility of the ANRS to take reasonable and appropriate regulatory actions to prevent and minimize damages derived from the use of unregistered products, substandard quality and counterfeit products.

On October 4, 2024, the National Authority of Sanitary Regulation ("ANRS”) of Nicaragua, through administrative resolution No. 0029/2024, approved the "Guide for the development of a market surveillance program to monitor the quality of products regulated by the ANRS throughout the supply chain”. This resolution establishes criteria for monitoring the quality of products regulated by the ANRS in the market and the responsibility of the ANRS to take reasonable and appropriate regulatory actions to prevent and minimize damage derived from the use of unregistered products, substandard quality products and counterfeit products.

Post-market surveillance activities will be carried out by the ANRS with the support of interested parties, including distributors, importers, exporters, manufacturers and authorized retailers, who may also be inspected to ensure compliance with good manufacturing, distribution and storage practices. Similarly, the ANRS will work in conjunction with other authorities, whether local or foreign, to carry out various product surveillance activities, from inspections to laboratory tests to determine product quality.

In accordance with the guide, in order to prevent the distribution and use of substandard, counterfeit or unregistered products in the Nicaraguan market, the ANRS will carry out the following activities: (i) the verification of good manufacturing, storage and distribution practices in the supply chain; (ii) the verification of the supply chain of products regulated by the ANRS, by verifying the origin and destination or transfer of possession; (iii) the identification of substandard and counterfeit products in the supply chain, through post-marketing surveillance and in coordination with security institutions, marketing authorization holders and the public; (iv) identification and investigation of actions, activities and behavior that contribute to the commercialization of substandard and counterfeit products; (v) collection of samples for verification and/or analysis; and (vi) withdrawal and/or prohibition of the distribution and use of substandard and counterfeit products that have been detected.

Similarly, for surveillance planning purposes, the ANRS will take different priority criteria, such as: (i) selection of products for post-market surveillance; (ii) selection of geographic areas for sampling; (iii) selection of sampling sites; and (iv) selection of sampling methods. For product selection, the guidance states that priority will be given to the following products: (i) products frequently used by large populations or public health programs; (ii) recently marketed medical products, including innovative products with less well-characterized safety profiles; (iii) non-medical products from genetically modified organisms; (iv) products with quality problems reported by national or foreign authorities; (v) medical products with reports of quality problems or counterfeiting within the World Health Organization's ("WHO”) Global Surveillance and Monitoring System, with relevance to the Central American and Caribbean region; (vi) products from unregulated and/or poorly regulated markets; and (vii) products with dangerous risk profiles.

In relation to geographical sampling areas, priority will be given to borders, coastal regions, ports of entry, clinics, and other vulnerable sites, and with respect to sampling sites, the criterion of local knowledge of the supply chain will be used in relation to availability, accessibility and information collected from consumers. Sampling will be conducted using a variety of methods, such as convenience sampling, random sampling, cluster sampling or lot quality assurance sampling.

For the handling of reports, upon receipt of information of suspected unregistered, substandard or counterfeit product, the ANRS will initially carry out the following actions: (i) establish contact with the notifier of the report; (ii) determine the reliability of the source; (iii) establish the facts of the case; (iv) determine the credibility of the information received; (v) obtain samples of the product and photographs identifying the lot number and expiration dates and all other relevant product information, including verification of product stocks; (vi) in the case of medical products, determine whether similar reports exist from regulatory authorities in the region and the WHO global surveillance and monitoring system database; and (vii) determine through market analysis the availability of therapeutic alternatives and their availability.

The ANRS in conjunction with the Quality Control Laboratory of the Ministry of Health ("MINSA”) may also perform tests on product samples, ranging from visual and physical inspection, simple and rapid screening tests, and even tests validated by pharmacopoeia, manufacturer's specifications and other applicable reference standards to evaluate all critical product quality attributes.

Depending on the level of risk of the product and the threat it poses to human health, the ANRS may take different regulatory actions. As a first step, it may take short-term actions (less than 72 hours) that include: (i) characterizing the activity or behavior by tracing the supply and retaining samples; (ii) containing the situation to prevent and reduce risks to public health, such as: bans, market withdrawal, support to patients and families, international reporting; and (iii) field actions or inspections.

The ANRS may also take medium-term actions (thirty calendar days) which include: (i) communicating information about the case to relevant parties, including publication and submission of reports to the WHO database and (ii) risk management, including quality investigation. Finally, it may take long-term actions (longer than thirty calendar days) that include: (i) final regulatory actions (registration modifications or cancellations, imposition of fines, closures, suspensions, etc); (ii) feedback to the surveillance program; and (iii) collaboration with other relevant authorities and stakeholders.