- 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?
- What are the approximate fees for each authorization?
- For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
- How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
- How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?
- How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
- What is the potential range of penalties for noncompliance?
- Is there a national healthcare system? If so, how is it administered and funded?
- How does the government (or public) healthcare system function with private sector healthcare?
- Are prices of drugs and devices regulated and, if so, how?
- How are drugs and devices used by patients paid for? What roles do public and private payers play?
- Who dispenses drugs and devices to patients and how are those dispensers compensated?
- What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
- What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
The authority responsible for applying and enforcing the regulatory framework in relation to drugs, biologicals, and medical devices is the Federal Commission for Protection against Sanitary Risks (COFEPRIS), which is a decentralized agency of the Ministry of Health.
- What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
The primary legislation for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices is the General Health Law (Ley General de Salud) (HL) and its Regulations. The laws and its regulations are supplemented by Guidelines and Official Norms (NOMS) published by COFEPRIS.
Price control in the private sector is based on a scheme of self-regulated maximum retail price (MRP) only covering patented products, overseen by the Ministry of Economy. Pharmaceutical companies' participation is voluntary. Under the price control each product's MRP must not exceed an international reference price, estimated as the average price in six major markets, plus a market factor. There are no established sanctions for violations of the MRP. In the private sector, there is no system for reimbursement in Mexico.
In the private sector, most payments are made on an out-of-pocket basis. Private insurers are improving the level of pharmaceutical coverage as the private market in medicines has grown considerably
Public acquisitions are supported by the Committee for the Negotiation of Drug Prices (CNDP).
For direct purchasing of patented products, the CNDP analyses the effectiveness of the drugs and relevant therapeutic alternatives and the feasibility and implications of an eventual substitution with equivalent medicines. The CNDP also conducts an economic evaluation of the cost-effectiveness of patented medicines compared with potential substitutes.
For the ISSSTE, a prescribed medicinal product can be dispensed in a private drug store registered with a public insurer, provided that this is not available within ISSSTE facilities and under certain conditions. The ISSSTE reimburses the cost of that product according to previous agreements.
The political party currently governing in Mexico (MORENA) is promoting an amendment to the scheme of self-regulated maximum retail price (MRP). The amendment state, in general terms, that the Ministry of Economy in collaboration with the Ministry of Health shall guarantee, through a transparent process and taking into consideration differentiated policies, the access to medications and inputs to people in situations of poverty. In addition, the price control would be regulated and annually reviewed by these Authorities.
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