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A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Chile. In Chile the regulatory authority responsible for the enforcement of the regulatory framework for pharmaceutical products, including biologicals, and medical devices is the Public Health Institute ISP , which is a functionally decentralized and autonomous public service overseen by the Ministry of Health MoH. In turn, the Ministry of Health is the main health authority in Chile, which, pursuant to the provisions of the Chilean Sanitary Code, is responsible for the issuance of the respective regulations which govern the import, clearance, export, production, manufacturing, fractioning, storage, handling, transport, distribution, sale, pharmacovigilance, traceability, advertising, promotion or information to professionals, medical use or scientific investigation of pharmaceutical products and for the progressive implementation of the provisions for medical devices. In Chile, the authorization for the commercialization of a pharmaceutical product is governed by the Sanitary Code, the regulations set forth in Supreme Decree No. Decree No. Medical devices are governed by the Sanitary Code and the regulations set forth in Supreme Decree No. Furthermore, medical devices law and regulations incorporate a progressive implementation through grounded Supreme Decrees issued by the Ministry of Health —prior report issued by the ISP—, indicating the specific medical devices which will need to fulfill the provisions included in the Sanitary Code and Supreme Decree No. Currently, regulated medical devices to which sanitary restrictions apply include latex surgical gloves for single use, latex medical examination gloves and latex condoms Decree No. There is no general regulatory reimbursement process or pricing laws for pharmaceutical products or medical devices. Nevertheless, the health coverage of pharmaceutical products and medical devices is based on a public and private insurance system and universal coverage programs, being the most relevant the Explicit Health Guarantees GES plan and the High Cost Treatment Financial Protection System Ley Ricarte Soto. Any pharmaceutical product, whether imported or manufactured in the country, requires a sanitary registration marketing authorization in order to be distributed or used under any title in Chile. A pharmaceutical product may be exceptionally authorized by the ISP to be used temporarily without prior sanitary registration if an epidemic, emergency or catastrophe occurs, or if required for an urgent medical use or for scientific research or clinical trials. We will later provide more information on the provisional use of pharmaceutical products. In general terms, for the sanitary registration of a pharmaceutical product the applicant will be required to comply with general requirements including the submission of administrative information, technical information, pharmaceutical quality information and data on safety and efficacy of the product. Special requirements will also be applicable for fixed dose combination pro-ducts, pharmaceutical combination products, phytopharmaceutical products; homeopathic products and biologicals. Safety and efficacy data, including full preclinical and clinical studies for the product will be necessary to be submitted in order to achieve the sanitary registration of a pharmaceutical product under the standard registration procedure procedimiento ordinario de registro , applicable, in general terms for innovator products. Nonetheless, Chilean regulations, in specific cases, also include the possibility to file for a simplified procedure procedimiento simplificado de registro , permitting the omission of specific safety and efficacy data, available for generics products, as will be described. Additionally, during , modifications were made to Supreme Decree No. As indicated above, full preclinical and clinical data on safety and efficacy will be required to be submitted under the standard procedure for sanitary registration of these products. For biotechnological products, and within the standard procedure of registration, Chilean regulations allow for the abbreviation of clinical data to certify the safety and efficacy provided such product has the same active ingredient, unitary dosage, pharmaceutical form and administration route than another registered reference product. This sets forth the possibility of a biosimilar pathway for specific biotechnological products. The biosimilar pathway, however, is only available for the active ingredients and their respective presentations included in Technical Guideline No. Technical Guideline No. It also includes provisions in connection to pharmacovigilance and extrapolation of indications. The administrative steps for the sanitary registration of a product under the standard procedure is described below:. The simplified procedure allows for the omission of specific data regarding safety and efficacy of the pharmaceutical product filed for registration and it is permitted, in general, for pharmaceutical products containing the same active ingredient, in the same pharmaceutical dosage form and the same administration route as another product which currently has or had in the past a sanitary registration granted by the ISP and which has not been cancelled for public safety issues. Specific therapeutic equivalence studies will be required for products containing active ingredients as per Decree No. The administrative steps for the sanitary registration of a product under the simplified procedure is described below:. On August 21st, , article 51 of Supreme Decree No. In the event that the abbreviated procedure petition is filed by the interested party, the application can be based on the following circumstances:. According to the regulation, the abbreviated procedure timelines should not exceed four months. Accelerated Procedure for the registration of Pharmaceutical Products accelerated pathway. On August 21st, , article 54 of Supreme Decree No. To request the accelerated registration procedure, the applicant must indicate in the application the existence of a sanitary registration or authorization for use granted by any of the following regulatory agencies High Surveillance Regulatory Agencies:. In order to obtain the sanitary registration of the pharmaceutical product under the accelerated procedure, the applicant must submit the same supporting information given to the Regulatory Agency that granted the registration reference agency , request the same therapeutical indication and submit the Certificate of Pharmaceutical Product CPP of the reference agency. The review carried out by the ISP must take into account the revision already performed by the respective reference Agency. According to article 99 of the Sanitary Code, the ISP may provisionally authorize the distribution, sale and use of pharmaceutical products without prior registration, for clinical trials or other types of scientific research, as well as for urgent medicinal uses derived from situations of shortage or inaccessibility that may affect people considered individually or collectively. In this sense, Decree No. In the case of letters a and b indicated above, they will be presented to the ISP proving, by any means, the authorization granted by the health authority of the country of origin or manufacture, as appropriate, and the prescription of the pharmaceutical product must be issued by a professional enabled to prescribe, stating the need and duration of the treatment with a maximum of 6 months of treatment for letter b. These authorizations may be requested by the interested party as many times as necessary. Concerning medical devices, as of today, only the following medical devices require a sanitary registration:. For regulated medical devices, the ISP will evaluate the product backgrounds based on the risk classification of the medical device. According to their class, medical devices must comply with quality, safety and efficacy requirements, which will be reviewed by ISP, and certification of the verification of conformity, granted by authorized entities or by the ISP in the absence of them. Sanitary registrations for pharmaceutical products will last for a period of 5 years, which is renewable for equal and successive periods, if not cancelled. Pursuant to article 20 of Supreme Decree No. In this regard, there are no differences for local manufacturers or foreign-owned manufacturers. As stated in question No. For biological products, the generic pathway or simplified procedure for registration is prohibited. Nevertheless, for specific biotechnological products included in Technical Guideline No. On the other hand, our regulation sets forth the simplified procedure procedimiento simplificado de registro , which is applicable for generic products. This pathway can be used for pharmaceutical products that have the same active ingredient, in the same amount per pharmaceutical form and the same route of administration as another product that was previously registered. The applicant in this procedure is not required to provide, with the sanitary application, the scientific information related to safety and efficacy required for the standard procedure, unless requested by the ISP by means of grounded resolutions. However, specific therapeutic equivalence studies will be required for products containing active ingredients as per Decree No. A pharmaceutical combination product is defined under Chilean regulations as a product comprising two or more pharmaceutical products included in a single packaging to be administered sequentially or simultaneously. For the registration of a pharmaceutical combination product, the applicant must submit all general applicable information as explained in question No. Furthermore, Chilean regulations requires for the applicant to prove the safety and efficacy of the proposed combined use of the pharmaceutical products and, additionally, demonstrate:. Pharmaceutical combination products may not include phytopharmaceuticals or homeopathic products, combined among themselves or with other pharmaceutical products. Combination of devices or devices with pharmaceutical products are not expressly regulated. Nevertheless, the ISP has expressed its criteria in the sense that products which combine a medical device with a pharmaceutical product having only an auxiliary function e. On the other hand, products which include a medical device and a pharmaceutical product as a single product e. Compliance with regulations is monitored and evaluated by the ISP through periodical inspections, which are previously scheduled by the authority or upon complaints or denouncements received by the authority anonymously or from third parties. Under the Sanitary Code and applicable regulations, the ISP and other sani-tary authorities are granted with ample faculties to visit, inspect and search any public or private site, to obtain and inspect records and documentation and to impose sanitary measures, applicable upon imminent risk and nece-ssary to safeguard public health. If, within the sanitary inspections performed by the ISP, a sanitary infringement is detected, the authority may open a sanctioning administrative procedure sumario sanitario , under which it may impose sanctions including fines or other penalties as indicated in question No. Penalties and sanctions for non-compliance of sanitary laws and regulations may be imposed by the ISP prior carrying out the respective sanctioning procedure sumario sanitario. The penalties which it may impose upon finding a sanitary infringement include fines ranging from USD 0. In case or repeated infringements, previously imposed fines can be duplicated. Additionally, the ISP can shut down the location or facility where the infringement is committed, prohibit its operation, revoke the permits or authorizations granted, suspend distribution of products, among other sanctions included in section of the Sanitary Code. Yes, there is a national healthcare system mainly formed and structured under Health Services Servicios de Salud , which are the entities responsible for the execution of actions of promotion, prevention, recovering of health and rehabilitation of patients, besides of enforcing the provisions of the Sanitary Code, when appropriate. For the developing of the referred actions, they are decentralized state entities, granted with their own legal personality and patrimony. The Assistance Network of each service is formed by the set of public healthcare assistance facilities that are part of the service. Members of the Chilean armed forces army, navy, air force have a special social security statute set forth by law No. The Chilean healthcare system is primarily structured by a mandatory medical coverage which is required by law. The law provides for a minimum medical coverage and the additional features depend on the health institution and the health plan chosen by each individual. The objective of the ISAPREs is to grant health benefits to its beneficiaries, whether giving them within their own attention units, or financing them by paying the services provided by clinics, hospitals and other institutions. Drugs will be dispensed within health entities hospitals and clinics or healthcare professionals directly pharmacist in the pharmacies. The professionals who dispense drugs must comply with all regulations applying to reception, storage, transport, distribution and dispensing of drug products. Additionally, they must be in possession of the title of Pharmacist. According to section A of the Sanitary Code, pharmacies must be under the supervision and technical direction of pharmacist who must supervise the correct dispensing of pharmaceutical products in accordance to the terms of the respective medical prescription and to personally inform a promote rational use of medicines, responding questions which patients may have. They shall also exert a permanent supervision of sanitary and technical aspects of the site, irrespective of the responsibility over administrative operation of the site which shall oversee the pharmacy staff. Supreme Decree No. In this regard, the technical director of the facilities, must verify and control the adequate dispatch of medical prescriptions assuring compliance with the conditions of sale approved for every product, assuring the correct storage conditions for pharmaceutical products are observed and training and supervising the pharmacy staff in their functions and in compliance with sanitary provisions, among others. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices? What are the steps to obtaining authorization to develop, test, and market a product? For products which include a modification in the composition and concentration of the active ingredients, or present new salts, esters, isoforms or complexes for an active ingredient of a previously registered product or constitute a fixed dose combination of active ingredients which, separately, may have or not prior sanitary approval. Products having a different dosage form of a previously registered product, modifying the release of the active ingredient. For the first registration of a combination pharmaceutical product As indicated above, full preclinical and clinical data on safety and efficacy will be required to be submitted under the standard procedure for sanitary registration of these products. Registration of the company before ISP. Registration of regulated medical device per product. Certificate of Review of the Antecedents that accompany the non-regulated medical device per product. Declaration of regulatory status of medical devices voluntary submission.