|
|
 |
|
Viewing report
|
|
|
|
The Pharmaceutical Market: Mexico
Espicom Business Intelligence Ltd, Jan 2010, Pages: 87
These highly regarded world pharmaceutical market reports have been redesigned to provide enhanced strategic intelligence in a user-friendly format. Each report provides in-depth information, setting the pharmaceutical market in context. The reports provide:
Five-year projections for economic, demographic, health expenditure, health workforce and pharmaceutical market indicators.
Specialised intelligence on OTCs, generics, biologics and biosimilars.
Exclusive economic and demographic data from the Economist Intelligence Unit (EIU) for each market in the series.
A separate statistical health file, comprising health expenditure, health infrastructure, health services and health personnel.
The reports are updated quarterly, providing you with the latest information for a full year. In addition, the service will keep you up to date with market and industry news on a regular basis.
Executive Summary
Mexico aims to become a global leader in the regulation of biologic and biosimilar medicines. The Federal National Commission for Protection against Health Risks (COFEPRIS) unveiled a draft to regulate these products in April 2010. The draft needs to be sent to the Federal Regulatory Improvement Commission (COFEMER). Once approved, it will be published in the official bulletin. The new regulation, however, was expected to be ready in December 2009. The enforcement of the regulatory reform to allow the sale and production of biologic and biosimilar medicines took place in September 2009. Under the reform, Article 222 Bis defines and regulates biologic and biosimilar medicines, including the requirements to register and market these medicines.
In March 2010, it was announced that antibiotic sales will be more regulated from August 2010 onwards, under Article 226, Fraction IV, of the General Health Law (LGS). As a result, customers will have to present prescriptions to buy antibiotics. Additionally, a national register will be created to control the date of sale, the INN of the medicine, the dispensed quantity, the name of the prescriber and further prescriber’s details. This means pharmacies which sell antibiotics without a prescription can be fined from August 2010; the fine will be up to 16,000 times the basic salary. This is part of the new agreement which determines the guidelines to sell antibiotics, expected to be published in May 2010.
Local manufacturing plant requirements are being phased out over a two-year period. Competition from foreign producers is going to increase, particularly from those which until now did not have the resources to establish manufacturing facilities in Mexico. Imports of antiretrovirals were released in August 2008. Imports of vitamins, homeopathic medicines, vaccines, sera, haemoderivatives, antitoxins and biologic hormones were released in February 2009. Producers of other biologics such as insulin and erythropoietin have been able to export to Mexico since August 2009. The liberation for narcotic or psychotropic drugs and OTC drugs took place in February 2010. The market will be fully open by mid-2010.
The reform of the Health Supplies Regulation, published in the Official Bulletin in January 2008, has ‘improved’ the renewal and registration processes of pharmaceuticals. As a result, there are only patented and bioequivalent generic drugs in the market since 24th February 2010. Of the 10,500 pharmaceuticals whose registrations needed to be renewed, COFEPRIS estimates that about 1,500 will exit the market following the February deadline. COFEPRIS aims to publish a list detailing the new registrations, the registrations in process and the cancelled registrations in May 2010.
Customers who bought this item also bought
The Pharmaceutical Market: Brazil
The Pharmaceutical Market: Thailand
Indian Pharmaceutical Industry: Issues and Opportunities
The Pharmaceutical Market: Slovenia
The Pharmaceutical Market: Portugal
The Pharmaceutical Market: New Zealand
The Pharmaceutical Market: India
New Zealand Vineyard & Wine Industry Review 2005
|
|
|
|
