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Pharma Regulatory Affairs in

Mexico

Maria Ines Guaia - Informa Conference: Regulatory Affairs in Emerging Markets - Prag...
Disclaimer
•

For educational purposes, some tables and graphs have been
borrowed from an informative COFEPRIS presentatio...
Mexico: an emerging economy

$1.177 trillion GDP

Services 70%

#14 World
#2 Latin America

Industry 26%

Annual growth ra...
Mexican GDP growth

Source: COFEPRIS
Mexican GDP growth
relative to US GDP growth

Source: COFEPRIS
Mexican balance of payments
Accounting record of all monetary transactions between a country and the rest
of the world. In...
Mexican fiscal deficit
Difference between public expenditure and income. Indicator of a government’s
budget and dependence...
Direct foreign investment
in Mexico

Source: COFEPRIS
Public expenditure in drug
products

Source: COFEPRIS
Public expenditure in drug
products - global comparison

Source: COFEPRIS
Out-of-pocket health
expenditure
as a percentage of total health expenditure

Source: COFEPRIS
The pharma industry in Mexico
% of GDP

1.2

% of manufacturing GDP

6.9

Annual exports (millions of USD)

2,200

Total p...
The pharma industry in Mexico
Mainly internal consumption (exports only 14% of production)

Source: COFEPRIS
COFEPRIS: the Mexican
Health Authority
Regulates:
• Food and beverages
• Tobacco products
• Healthcare supplies
(including...
COFEPRIS: the Mexican
Health Authority
July 2012: COFEPRIS recognized as Health Authority of Regional
Reference

COFEPRIS
...
Drug product

Registration in Mexico
General
overview
Drug registration in Mexico
Timeline to approval

Registration period: 5 years

officially: 6 months
In reality: very vari...
Dossier structure
for the different registration cases
Vaccines

New Molecules
•
•
•
•

Module I. Legal/Administrative
inf...
Dossier structure
content of the modules
Module I. Legal/Administrative information
1.
2.
3.

4.
5.
6.
7.
8.
9.
10.

11.
1...
Dossier structure
content of the modules
Module II. Quality information
1. API
1.1. Manufacturing information
1.2. General...
Dossier structure
content of the modules
Module II. Quality information (cont.)
3. Finished product
3.1. Pharmaceutical de...
Dossier structure
content of the modules
Module II. Quality information (cont.)
4. Packaging materials
4.1. Description an...
Dossier structure
content of the modules
Module III. Preclinical studies (for new molecules, vaccines, orphan drugs).
1. P...
Dossier structure
content of the modules
Module III. Bioavailability and/or bioequivalence (for generic drug products)
1. ...
Biotech regulations:

Mexico at the vanguard

Late ‘90s

1997

1998

Some legal
adaptations to
include
innovative
biotech ...
Drug registration in Mexico
foreign manufacturers
Until August 2008: local
manufacturing site requirement
the solicitor of...
New Molecule Committee
For registration of novel compounds
Presentation at the New
Molecule Committee
Cases in which a drug is considered a “New Molecule”
• New drug substances (new...
Pre-revision of submission dossiers by

Authorized Third Parties
A solution for eternal approval timelines
Pre-revision of dossier
Starting in 2012, the possibility of having submission dossiers pre-revised by
private parties esp...
Significant reduction in
processing times!

NEW August 2013: expansion of the Third Authorized Parties’ pre-revision
schem...
GMP verification and
certification
GMP verification by COFEPRIS
GMP Certificates issued by FDA

When?
• For new registration and manufacturing
changes of bio...
Required info and documents
•

Name and general data of the applying company,
authorization

•

Name of DP/DS – use, actio...
Clinical trials in Mexican
population
Local Clinical Trials in Mexico
• Why?
Pharmacogenomic studies have shown that
drug
metabolism
in
Mexican-Hispanic
populat...
Agreement for innovation
October 2012
Agreement for Innovation
Three main tenants
1. Give

strong support for innovation projects proposed by the
national secto...
Agreement for Innovation
Results: reduction in dossier revision times

Source: COFEPRIS
Agreement for Innovation
Concrete results
•

88 new innovative drug products have entered the Mexican market,
most of them...
Coming soon:
Regulations on personalized
medicine/pharmacogenomics
Regulations on personalized
medicine
Guidelines coming soon
•

Guidelines to guarantee safety and effectiveness of persona...
Thank you! Gracias! Děkuji!
www.niniguaia.wordpress.com
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Pharma Regulatory Affairs in Mexico

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  • Hi!!! Maria,

    Nice presentations, do you have same kind of presentations on Honduras, El Salvador, Guatemala and Nicaragua???
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • Hi Maria

    great slide deck!

    Do you have any information regarding:

    third party evaluation process

    agreement for innovation?



    Thank you for your assistance.

    Regards

    Kirti
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here

Pharma Regulatory Affairs in Mexico

  1. 1. Pharma Regulatory Affairs in Mexico Maria Ines Guaia - Informa Conference: Regulatory Affairs in Emerging Markets - Prague, October 2013
  2. 2. Disclaimer • For educational purposes, some tables and graphs have been borrowed from an informative COFEPRIS presentation. You can find the complete original presentation in the following link: http://www.deloitte.com/assets/DcomMexico/Local%20Assets/Documents/mx(esmx)PanoramaMexico_IndustriaCofepris.pdf
  3. 3. Mexico: an emerging economy $1.177 trillion GDP Services 70% #14 World #2 Latin America Industry 26% Annual growth rate: 3.9 (2012) 3.5 (exp. 2013) Agriculture 4% 120 million people (est. 2012) 46% below poverty line
  4. 4. Mexican GDP growth Source: COFEPRIS
  5. 5. Mexican GDP growth relative to US GDP growth Source: COFEPRIS
  6. 6. Mexican balance of payments Accounting record of all monetary transactions between a country and the rest of the world. Indicator of a country's position in the global economy. Source: COFEPRIS / Data: 2010
  7. 7. Mexican fiscal deficit Difference between public expenditure and income. Indicator of a government’s budget and dependence on credit. Source: COFEPRIS / Data: 2011
  8. 8. Direct foreign investment in Mexico Source: COFEPRIS
  9. 9. Public expenditure in drug products Source: COFEPRIS
  10. 10. Public expenditure in drug products - global comparison Source: COFEPRIS
  11. 11. Out-of-pocket health expenditure as a percentage of total health expenditure Source: COFEPRIS
  12. 12. The pharma industry in Mexico % of GDP 1.2 % of manufacturing GDP 6.9 Annual exports (millions of USD) 2,200 Total pharma market (billions of dollars) 13 Direct employment 78,500 Indirect employment 330,000 2nd biggest in LatAm 11th biggest worldwide Source: COFEPRIS Steady annual growthrate 2005-2011: average of 4.8%
  13. 13. The pharma industry in Mexico Mainly internal consumption (exports only 14% of production) Source: COFEPRIS
  14. 14. COFEPRIS: the Mexican Health Authority Regulates: • Food and beverages • Tobacco products • Healthcare supplies (including drugs, medical devices, vaccines, blood and tissues, etc.) • Healthcare services • Other consumer goods (cosmetics) • Pesticides, plant nutrients and toxic substances • Emergencies • Occupational health • Environmental risks 92 billion $ market! (around 10% of GDP) Through all the supply chain • Production • Distribution • Commercialization • Imports • Exports • Advertisement • Sales and supply
  15. 15. COFEPRIS: the Mexican Health Authority July 2012: COFEPRIS recognized as Health Authority of Regional Reference COFEPRIS Commisionate: Mikel Arriola Photo: PAHO Other ARRs: ANVISA (Brazil), ANMAT (Argentina), INVIMA (Colombia), CECMED (Cuba)
  16. 16. Drug product Registration in Mexico General overview
  17. 17. Drug registration in Mexico Timeline to approval Registration period: 5 years officially: 6 months In reality: very variable and changing 12 – 24 months Submission for registration renewal: at least 6 months before registration expiry new entity Small molecules Registration cases Biotechs generic new entity biocomparable Vaccines Orphan drugs Before submission: Committee of New Molecules
  18. 18. Dossier structure for the different registration cases Vaccines New Molecules • • • • Module I. Legal/Administrative information Module II. Quality information Module III. Preclinical studies Module IV. Clinical studies • • • • Orphan drugs Generic drugs • • • Module I. Legal/Administrative information Module II. Quality information Module III. Bioavailability and/or bioequivalence Module I. Legal/Administrative information Module II. Quality information Module III. Preclinical studies Module IV. Clinical studies • • • • • Module I. Legal/Administrative information Module II. Quality information Module III. Justification of ‘orphan drug’ status Module IV. Preclinical studies Module V. Clinical studies
  19. 19. Dossier structure content of the modules Module I. Legal/Administrative information 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Form. Proof of payment of fee. Sanitary authorization. (licencia sanitaria) For foreign manufacturing site provide licence, certificate or other document authorizing the site to manufacture the pharmaceutical products of interest, issued by country of origin, legalized or apostilled, translated to Spanish by an official translator (perito traductor). ‘Responsible sanitario’ notice. Labeling texts (if applicable). Complete and summarized prescription information. GMP certificate for manufacturing site of API. GMP certificate for manufacturing site of finished product. GMP certificate for manufacturing site of diluent (if applicable). For drug products manufactured outside of Mexico: Certificate of Pharmaceutical Product (CPP) of origin, apostilled or legalized, with official translation (perito traductor). Representation letter, assigning the legal representative of the foreign company in Mexico. (Reccomended: broad power of representation letter, minimum validity time of 5 years. Commercial name. Intellectual property information. Information on the waiver for the local manufacturing facility requirement.
  20. 20. Dossier structure content of the modules Module II. Quality information 1. API 1.1. Manufacturing information 1.2. General information 1.3. Quality control 1.3.1. Literature/Pharmacopoeial references. Specifications. Analytical methods. Validation reports. Certificates of analysis (CoAs). 2. Excipients and additives 2.1. For new additives, usage safety information 2.2. Quality control 2.2.1. Literature/Pharmacopoeial references. Specifications. Analytical methods. Validation reports. Certificates of analysis (CoAs).
  21. 21. Dossier structure content of the modules Module II. Quality information (cont.) 3. Finished product 3.1. Pharmaceutical development 3.2. Formula 3.3. Manufacturing information 3.3.1. Manufacturing/packaging order, in-process controls. 3.4. Quality control 3.4.1. Monograph 3.4.2. Specifications 3.4.3. Analytical methods and validation reports (if applicable) 3.4.4 Certificates of analysis (CoAs). 3.5 Stability 3.5.1 Stability protocol 3.5.2. Tabulated stability data 3.5.3 Analytical evidence for first and final testing points. 3.5.4 Conclusions
  22. 22. Dossier structure content of the modules Module II. Quality information (cont.) 4. Packaging materials 4.1. Description and capacity of primary packaging materials. 4.2. Description and capacity of secondary packaging materials. 4.3. Description, capacity and information of any additional materials or devices.
  23. 23. Dossier structure content of the modules Module III. Preclinical studies (for new molecules, vaccines, orphan drugs). 1. Preclinical studies 1.1. Pharmacodynamics' studies 1.2. Pharmacokinetic studies 1.3. Toxicology Module IV. Clinical studies (for new molecules, vaccines, orphan drugs). 1. Clinical studies 1.1. Phase I studies 1.2. Phase II studies 1.3. Phase III studies 1.4. Phase IV studies (if applicable) 1.5. For combination of two or more drugs: risk-benefit assessment.
  24. 24. Dossier structure content of the modules Module III. Bioavailability and/or bioequivalence (for generic drug products) 1. Type of test 1.1. A 1.2. A (3) 1.3. B 1.4. C
  25. 25. Biotech regulations: Mexico at the vanguard Late ‘90s 1997 1998 Some legal adaptations to include innovative biotech drug products Modification of General Health Law – all biotech products Inclusion of some concepts and guidelines in Health Supplies Regulation 2004 2005 USA – EU EU: First specific started guidelines discussions on regulations for SBP +170 biotech drug products approved 2007 2009 Starts congress discussion in Mexico Modification to Health General Law – general principles for SBP Development of specific, detailed regulation COFEPRIS, industry, other actors Oct 2011 – April 2012 Modification of General Health Law Sep 2012 Operative guidelines became effective
  26. 26. Drug registration in Mexico foreign manufacturers Until August 2008: local manufacturing site requirement the solicitor of a registration had to own a manufacturing facility in Mexico Foreign manufacturer • • License to manufacture medical products GMP certificate Currently: Solicitor must hold license, permit or similar document issued by the country of origin authorizing the manufacturing of medical products Legal representative Warehouse (storage and distribution) Importer (Mexican company) Lab of Analysis (Authorized Third Parties) Unit of pharmacovigilanc e Sanitary responsible
  27. 27. New Molecule Committee For registration of novel compounds
  28. 28. Presentation at the New Molecule Committee Cases in which a drug is considered a “New Molecule” • New drug substances (new in the world or new for Mexico) • New combinations of drug substances (for Mexico) • New indications • Other special cases (e.g. similar biotherapeutic products) 1- Request meeting with the New Molecule Committe. (before dossier submission) 2- Presentation by company on the product, followed by questions by the members of the committee. 3- After the meeting, the committee will issue a report thet will be attached to the dossier for submission.
  29. 29. Pre-revision of submission dossiers by Authorized Third Parties A solution for eternal approval timelines
  30. 30. Pre-revision of dossier Starting in 2012, the possibility of having submission dossiers pre-revised by private parties especially authorized by COFEPRIS was introduced. How does it work? After all the necessary meetings and exchange of information, the ATP will issue a technical report. If this final report is positive, it can be attached to the submission package for registration. This submission package will enter the COFEPRIS through a special fast-track channel and will be revised in a much shorter time than applications going through the conventional channel. This option is available for new drug applications, renewal of registration certificate and variations. COFEPRIS doesn’t have any inference in the relations and terms of agreement between clients and ATP. Main benefits of this new option • Cut current revision times. • Avoid unnecessary deficiency letters. The technical report that the ATP issues does not replace the evaluation and decision by COFEPRIS.
  31. 31. Significant reduction in processing times! NEW August 2013: expansion of the Third Authorized Parties’ pre-revision scheme to include biotech products Source: COFEPRIS
  32. 32. GMP verification and certification
  33. 33. GMP verification by COFEPRIS GMP Certificates issued by FDA When? • For new registration and manufacturing changes of biologic, biotech and hemoderivate products. • For new registration or renewal of drug products or drug substances of any kind manufactured in countries not considered as high sanitary surveillance by COFEPRIS. Inspection is required prior to submission the certificate is an important document to be annexed to the submission dossier What? Manufacturing sites of drug substance and drug product – DP/DS specific (USA), ANVISA (Brazil), Health Canada (Canada), EMA (EU), Pharmaceutical and Food Safety Bureau (Japan), and Therapeutic Goods Administration (Australia) are accepted. Cooperation within the Pacific Alliance bloc and with other Sanitary Authorities of Regional Reference Request for inspection • Submit form and required documents • Propose two inspection dates (production of DS/DP) and inspection schedule • Propose hotel and flight options. Cost of visit + travel expenses: company • Arrange a Spanish translator • Timeline to get an inspection: about 3 months
  34. 34. Required info and documents • Name and general data of the applying company, authorization • Name of DP/DS – use, action, indication • Name and address of all sites involved in manufacturing process, description of process stages • Manufacturing process – list and description of other DS/DP manufactured in same line • Person designated by the applicant to be in charge • Technical documents:  Organization charts  Architectural drawings  Flowchart of manufacturing process  General summary of quality system  Validation master plan  Two last annual product reports Payment • All documents in Spanish, or English with Spanish translation, verified and signed by technical responsible Documents issued by foreign authorities: apostilled or legalized and translated by certified translator NEW! AUGUST 2013: Open call to private parties to enroll as inspectors for DS and DP facilities (Authorized Third Parties)
  35. 35. Clinical trials in Mexican population
  36. 36. Local Clinical Trials in Mexico • Why? Pharmacogenomic studies have shown that drug metabolism in Mexican-Hispanic population can be influenced by its genetic makeup. • In which cases? Local clinical studies are required by COFEPRIS for: • New molecules • Biotech and biocomparable products • Generic drugs that are not commercialized anywhere else in the world. • Other cases upon authority request • When? • Previous submission and approval of clinical protocol – Have results before submission for registration. • How? When clinical studies are multicentric, Mexican population must be included. Sample size: not specified in regulations; to be calculated based on incidence of disease. If Mexican patients are not included in the clinical trials: New Molecule Committee will request pharmacokinetic studies to evidence not significant differences in safety or efficacy in Mexicans. • Good Clinical Practices guidelines
  37. 37. Agreement for innovation October 2012
  38. 38. Agreement for Innovation Three main tenants 1. Give strong support for innovation projects proposed by the national sector: expedition of approval of clinical protocols to be carried out in Mexican clinical centers, follow-up on the execution of the studies, and expedition of registration approval timelines for drug products manufactured in Mexico, from the current average of 240 working days to 60. 2. Strengthen the import of innovative drugs to the Mexican market: recognition of product registrations in the USA, Canada, Switzerland, Australia and the EU and expedition in registration approval timeline for drug products being marketed in any of these countries from a current average of 360 working days to 60. 3. Make Mexico the first country of commercialization of new innovative drug products: modification of the Regulations for Healthcare Supplies: the previously compulsory requirement of providing a CPP of origin offers now the alternative of being waived if a report of clinical trials on Mexican population is submitted.
  39. 39. Agreement for Innovation Results: reduction in dossier revision times Source: COFEPRIS
  40. 40. Agreement for Innovation Concrete results • 88 new innovative drug products have entered the Mexican market, most of them through the expedited revision process for registration of innovative imported drugs registered in high-sanitary-surveillance countries, and including five orphan drugs. Most of the newly approved drugs target cardiovascular, oncologic or cerebrovascular conditions. • Increase of 20% from 2011 to 2013 in applications for clinical trials in Mexico (current figure: 388 applications), and COFEPRIS is implementing measures to decentralize the revision of clinical protocols to the National Institutes of Health in order to reduce evaluation times, from 90 to 30 days. • In January 2013, one new drug was approved in Mexico before any other country in the world, making Mexico a worldwide pioneer for an innovative drug product for the first time: Lixisenatide (Sanofi Pasteur), trade name Lyxumia, the latest pharmaceutical innovation to treat Type 2 Diabetes, a once-daily injectable GLP-1 receptor agonist.
  41. 41. Coming soon: Regulations on personalized medicine/pharmacogenomics
  42. 42. Regulations on personalized medicine Guidelines coming soon • Guidelines to guarantee safety and effectiveness of personalized therapies based on pharmacogenomics approach • Define specific GMP requirements for pharmacogenomics-based products. • Make Mexico a pioneer in regulation for this kind of product in Latin America.
  43. 43. Thank you! Gracias! Děkuji! www.niniguaia.wordpress.com

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