The relevant procedures are commented as follows.
Essentially, applicants for marketing authorisations must prove the safety and efficacy of their products through standard clinical trials, according to the rules set out by the HL, its regulations and NOMs of good manufacturing of medicines and active ingredients.
Concurrently, they have to request approval of their products as new molecules by the New Molecules Committee of COFEPRIS. A new molecule is (article 2, section XV of the HLR):
- an active ingredient or drug not approved worldwide (new molecular entity);
- an active ingredient or drug already available in other countries but with limited clinical experience or disputed information, without approval in Mexico;
- a drug that is a non-marketed combination of two or more active ingredients; and
- an active ingredient or drug already available in the market, but to be marketed for a new therapeutic indication.
R&D companies can benefit from a special procedure for drugs to be approved for the first time in Mexico, if they have been previously approved by:
- the European Medicines Agency;
- the US Drug and Food Administration;
- Health Canada;
- the Swiss Agency for Therapeutic Products (Swissmedic); and
- the Therapeutic Goods Administration in Australia.
This special procedure is essentially based on the dossier filed with the foreign regulatory agency, to reduce approval time frames by up to 60 working days. Industry participants have welcomed and used these new rules.
Applicants for marketing authorisations have to prove basically that their products are bioequivalent to the innovator product. They have to provide information concerning dissolution profiles or bioavailability studies regarding the reference product. COFEPRIS periodically issues a list of reference medicinal products.
The Mexican Official Norm NOM-177-SSA1-2013 sets standards of tests to prove that a generic drug is interchangeable with a reference drug. Legally speaking, COFEPRIS should not grant marketing authorisation for generics breaching exclusivity rights.
There is a linkage system between COFEPRIS and the Mexican Institute of Industrial Property (IMPI), which aims to prevent the granting of marketing authorisations in violation of exclusive rights. According to the IP Regulations, every six months the IMPI must publish a gazette that includes patents covering allopathic medicines (Linkage Gazette). The initial IMPI position was that only patents relating to a compound were relevant to linkage review (excluding formulation and use of patents). In 2012, for the first time the IMPI included formulation patents in the Linkage Gazette, in accordance with a 2010 ruling of the Mexican Supreme Court (Jurisprudence No. 2a./J.7/2010, Federal Judicial Gazette, No. XXXI, page 135).
Under the linkage regulations, at the filing of the application, the applicant must prove that it is the owner or licensee of the patent of the active ingredient of the product (recorded with the IMPI), or state under oath that their application does not violate the list of products published in the Linkage Gazette and observes patent law.
Biologics (biotech products)
The Mexican jurisdiction recognises already that biotech products deserve special treatment as a result of their distinct characteristics, such as their complex structures, their size in comparison with chemically synthetised drugs and, particularly, their susceptibility to variation during manufacturing. The regulatory scheme distinguishes from other biologics those products that have been manufactured by molecular biotechnology and provides a robust regulatory process to approve them.
The standards to approve biotech products are essentially the same as for other drugs in Mexico: they must be safe and effective and have appropriate quality. The biotech products, however, must comply with a number of additional dossier requirements, in view of their distinct characteristics. Applicants have to prove quality, safety and efficacy requirements under the HL, its regulations and applicable NOMs, particularly, those for biotech products (NOM-257-SSA1-2014), for good manufacturing practices for medicinal products (NOM-059-SSA1-2015) and for active ingredients (NOM-164-SSA1-2015).
Applicants must submit clinical tests and, when appropriate, in vitro tests, to prove safety, efficacy and quality of this product comparable (similar) to those of the reference biologic.
The pre-clinical and clinical test used by an applicant for a biocomparable must use the corresponding reference biologic to perform comparative and physic0-chemical studies. For this, the applicant must have to submit essentially:
- in vitro studies;
- a report of comparative test of pharmacokinetics, if determined by the Ministry of Health, to show pharmacokinetic comparability on key parameters between both the follow-on and the reference biologic;
- pharmacodynamics test reports; and
- a comparative efficacy and safety clinical test to show similarity between both the follow-on and the reference biologic.
Although industry participants welcomed amendments to approve biologics, specific rules to approve follow-ons have caused debate. In Mexican domestic law there is currently no indication of a data-protection period for biologics. The recognition of data package exclusivity rights for biologics has been achieved through litigation.
They were introduced into the HL and the Mexican Pharmacopeia some years ago. In practice, they are approved by a particular procedure, following rules for new molecules when applicable and appropriate.
New trends on use of cannabis
In April 2017, the Mexican Congress amended the HL to expressly authorise the use of cannabis and other narcotics for medical and scientific use.
Most recently, on 30 October 2018, COFEPRIS published the expected guidelines to establish the criteria for the appraisal of applications of authorisations for the commercialisation, exploitation, and importation of products with broad industrial uses that contain cannabis and its derivative in concentrations less than 1 per cent of tetrahydrocannabinol (THC).
The guidelines include the following rules:
- the protocols for clinical and scientific investigation using cannabis;
- definition, description and limitation of activities related to the medical use of cannabis;
- import and export requirements and conditions;
- rules for the use of THC in food, beverages and supplements;
- rules for the use of THC in herbal supplements;
- other industrial uses;
- publicity and advertising; and
- enforcement, inspections and sanctions.
These rules are already in full force.
One day after these guidelines were published, on 31 October 2018, the Mexican Supreme Court conformed jurisprudence related to the casual or recreational use of cannabis.
In short, the Mexican Supreme Court decided that, in order to preserve the right to personal freedom, the individual use of cannabis for recreational or casual use should be authorised. In order for this jurisprudence to be applicable, the individual should file a Constitutional Action (amparo) against COFEPRIS´ refusal to authorise personal use of cannabis for recreational use, because the jurisprudence of the case will be decided on behalf of applicant. The ruling includes the conditions that individuals should request the right to recreational use of cannabis in adulthood (more than 18 years old), and that this right cannot be exercised in public places where third parties have not expressed their consent, nor in the presence of minors.
The new government will take office on 1 December 2018. It has already announced, along with the Congress, that there is a proposal for a new bill to regulate and control the process of harvesting, storage, transportation, labelling, production, publicity, sponsorship, sales and commercialisation of cannabis.
- cannabis in Mexico is already legal for medical and scientific use;
- under certain conditions, some adult individuals will be allowed to use cannabis for recreational purposes; and
- a new law is expected to once and for all legalise and control the use of cannabis in Mexico.
These three legal developments are breaking the traditional taboo in Mexico against the legalisation and control of marijuana and other narcotics.
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