- Mexico has a $1.177 trillion GDP and annual growth rate of 3.9% in 2012 and projected 3.5% in 2013, with services accounting for 70% of GDP.
- The pharmaceutical industry in Mexico accounts for 1.2% of GDP and 6.9% of manufacturing GDP, with annual exports of $2.2 billion and a total market of $13 billion. The industry employs over 78,500 directly and 330,000 indirectly.
- COFEPRIS is the Mexican health authority that regulates the pharmaceutical, medical device, and healthcare industries, representing a $92 billion market. It oversees all aspects of the supply chain from production to advertising.
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
Regulatory requirements for drug approval in Saudi ArabiaSridhar S
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
Regulatory requirements for drug approval in Saudi ArabiaSridhar S
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
REGISTRATION.VN helps you to have an overview of the regulations and procedures relating to registration of the products managed by Vietnamese Ministry of Health (such as registration of foreign companies doing Medicine business, drug registration, quota to import raw materials for medicines, registration for food supplements, cosmetics, medical equipment ...)
New Drug approval process in India, rules, and regulation according to schedule Y (Drug and cosmetics act 1940 ).
Fees and form for the submission of application.
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
REGISTRATION.VN helps you to have an overview of the regulations and procedures relating to registration of the products managed by Vietnamese Ministry of Health (such as registration of foreign companies doing Medicine business, drug registration, quota to import raw materials for medicines, registration for food supplements, cosmetics, medical equipment ...)
New Drug approval process in India, rules, and regulation according to schedule Y (Drug and cosmetics act 1940 ).
Fees and form for the submission of application.
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
Regulatory aspect of pharamacutical packgingvineet gupta
There is no doubt that the regulatory climate is getting more restrictive for pharmaceutical products and it is likely that packaging for pharmaceuticals will have more and more constraints placed upon it.
New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
"Pharmaceutical sciences
and the challenge for a healthcare focused agenda for pharmacists training"
(A interface ensino-profissão no desenvolvimento das Ciências Farmacêuticas)
Rogério Gaspar
(Presidente da SPCF)
21.SET.2016
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
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Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
1. Pharma Regulatory Affairs in
Mexico
Maria Ines Guaia - Informa Conference: Regulatory Affairs in Emerging Markets - Prague, October 2013
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. 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
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. Mexican fiscal deficit
Difference between public expenditure and income. Indicator of a government’s
budget and dependence on credit.
Source: COFEPRIS / Data: 2011
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. The pharma industry in Mexico
Mainly internal consumption (exports only 14% of production)
Source: COFEPRIS
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. 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)
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. 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. 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. 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. 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. 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. 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. 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. 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. 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
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. Pre-revision of submission dossiers by
Authorized Third Parties
A solution for eternal approval timelines
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. Significant reduction in
processing times!
NEW August 2013: expansion of the Third Authorized Parties’ pre-revision
scheme to include biotech products
Source: COFEPRIS
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. 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)
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
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.
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.
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.
The service sector employs around 70% of the active population and includes transportation, commerce, warehousing, restaurant and hotels, arts and entertainment, health, education, financial and banking services, telecommunications as well as public administration and defense. Mexico's service sector is strong, and hasreplaced Brazil's as the largest service sector in Latin America in value.Industry is a growing sector, the main areas are Aircraft, automobile industry, petrochemicals, cement and construction, textiles, food and beverages, mining, consumer durables and tourism. It has benefited from trade liberalization.
The service sector employs around 70% of the active population and includes transportation, commerce, warehousing, restaurant and hotels, arts and entertainment, health, education, financial and banking services, telecommunications as well as public administration and defense. Mexico's service sector is strong, and hasreplaced Brazil's as the largest service sector in Latin America in value.Industry is a growing sector, the main areas are Aircraft, automobile industry, petrochemicals, cement and construction, textiles, food and beverages, mining, consumer durables and tourism. It has benefited from trade liberalization.
The service sector employs around 70% of the active population and includes transportation, commerce, warehousing, restaurant and hotels, arts and entertainment, health, education, financial and banking services, telecommunications as well as public administration and defense. Mexico's service sector is strong, and hasreplaced Brazil's as the largest service sector in Latin America in value.Industry is a growing sector, the main areas are Aircraft, automobile industry, petrochemicals, cement and construction, textiles, food and beverages, mining, consumer durables and tourism. It has benefited from trade liberalization.
The service sector employs around 70% of the active population and includes transportation, commerce, warehousing, restaurant and hotels, arts and entertainment, health, education, financial and banking services, telecommunications as well as public administration and defense. Mexico's service sector is strong, and hasreplaced Brazil's as the largest service sector in Latin America in value.Industry is a growing sector, the main areas are Aircraft, automobile industry, petrochemicals, cement and construction, textiles, food and beverages, mining, consumer durables and tourism. It has benefited from trade liberalization.
The service sector employs around 70% of the active population and includes transportation, commerce, warehousing, restaurant and hotels, arts and entertainment, health, education, financial and banking services, telecommunications as well as public administration and defense. Mexico's service sector is strong, and hasreplaced Brazil's as the largest service sector in Latin America in value.Industry is a growing sector, the main areas are Aircraft, automobile industry, petrochemicals, cement and construction, textiles, food and beverages, mining, consumer durables and tourism. It has benefited from trade liberalization.
The service sector employs around 70% of the active population and includes transportation, commerce, warehousing, restaurant and hotels, arts and entertainment, health, education, financial and banking services, telecommunications as well as public administration and defense. Mexico's service sector is strong, and hasreplaced Brazil's as the largest service sector in Latin America in value.Industry is a growing sector, the main areas are Aircraft, automobile industry, petrochemicals, cement and construction, textiles, food and beverages, mining, consumer durables and tourism. It has benefited from trade liberalization.
The increase in public expenditure in healthcare is directly reflected in the expenditure in medicines, which grew 86% between 2005 and 2011.
Mexico is the second country of the Organization for Economic Cooperation and Development in expenditure in medicines as a percentage of the total expenditure in healthcare. The expenditure in medicines as a percentage of the GDP is also above the OECD average.
During the period 2005-2011, the out-of-pocket health expenditure decreased by 9%, at an average annual rate of -1.5, as a result of the effort of the federal government to implement policies of universal healthcare, such as incentives to import, production and commercialization of generic drugs.
InLatAm: after BrazilWorldwide: after USA, Japan, Germany, China, France, Canada, Brazil, Italy, Spain and the UK
InLatAm: after BrazilWorldwide: after USA, Japan, Germany, China, France, Canada, Brazil, Italy, Spain and the UK
The service sector employs around 70% of the active population and includes transportation, commerce, warehousing, restaurant and hotels, arts and entertainment, health, education, financial and banking services, telecommunications as well as public administration and defense. Mexico's service sector is strong, and hasreplaced Brazil's as the largest service sector in Latin America in value.Industry is a growing sector, the main areas are Aircraft, automobile industry, petrochemicals, cement and construction, textiles, food and beverages, mining, consumer durables and tourism. It has benefited from trade liberalization.
In Mexico the drug registration procedure will depend on the type of product that it is intended to get registered.After document submission, the official timeline for an answer is 6 months. Until last year, the norm was between 1 and 2 years. Last, year, a new option was introduced which contemplates the possibility of having third parties (consultants) previously evaluated and approved by COFEPRIS, do a pre-evaluation of the dossiers, which expedites the posterior revision by COFEPRIS, and at the same times lightens the burden for the evaluators at the health authority, allowing a quickest revision of all submissions.
Before submission for registration, all quality, efficacy and security information has to be reviewed by the New Molecule Committee.Submission package consists of:FormStability studiesEfficacy and safety information (publications, studies)Labeling textsPatent or licensing documentsOrigin identification and GMP certificate for DS+DPTechnical information for raw materials:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsTechnical information for finished product:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsCopy of manufacturing orders of batches used for stability testsTechnical information for packaging materials:Description and capacity of primary and secondary packaging materialsFor primary packaging: tightness test, results and bibliographic referenceCopy of packaging orders of batches used for stability testsIf the drug product will be manufactured in a country different than Mexico, these additional documents must be included:CPP of originDS+DP GMP certification of origin by a recognized country (apostilled/legalized)Authenticated representation letter, if solicitor is not affiliate or headquarter of manufacturing company
Before submission for registration, all quality, efficacy and security information has to be reviewed by the New Molecule Committee.Submission package consists of:FormStability studiesEfficacy and safety information (publications, studies)Labeling textsPatent or licensing documentsOrigin identification and GMP certificate for DS+DPTechnical information for raw materials:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsTechnical information for finished product:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsCopy of manufacturing orders of batches used for stability testsTechnical information for packaging materials:Description and capacity of primary and secondary packaging materialsFor primary packaging: tightness test, results and bibliographic referenceCopy of packaging orders of batches used for stability testsIf the drug product will be manufactured in a country different than Mexico, these additional documents must be included:CPP of originDS+DP GMP certification of origin by a recognized country (apostilled/legalized)Authenticated representation letter, if solicitor is not affiliate or headquarter of manufacturing company
Before submission for registration, all quality, efficacy and security information has to be reviewed by the New Molecule Committee.Submission package consists of:FormStability studiesEfficacy and safety information (publications, studies)Labeling textsPatent or licensing documentsOrigin identification and GMP certificate for DS+DPTechnical information for raw materials:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsTechnical information for finished product:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsCopy of manufacturing orders of batches used for stability testsTechnical information for packaging materials:Description and capacity of primary and secondary packaging materialsFor primary packaging: tightness test, results and bibliographic referenceCopy of packaging orders of batches used for stability testsIf the drug product will be manufactured in a country different than Mexico, these additional documents must be included:CPP of originDS+DP GMP certification of origin by a recognized country (apostilled/legalized)Authenticated representation letter, if solicitor is not affiliate or headquarter of manufacturing company
Before submission for registration, all quality, efficacy and security information has to be reviewed by the New Molecule Committee.Submission package consists of:FormStability studiesEfficacy and safety information (publications, studies)Labeling textsPatent or licensing documentsOrigin identification and GMP certificate for DS+DPTechnical information for raw materials:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsTechnical information for finished product:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsCopy of manufacturing orders of batches used for stability testsTechnical information for packaging materials:Description and capacity of primary and secondary packaging materialsFor primary packaging: tightness test, results and bibliographic referenceCopy of packaging orders of batches used for stability testsIf the drug product will be manufactured in a country different than Mexico, these additional documents must be included:CPP of originDS+DP GMP certification of origin by a recognized country (apostilled/legalized)Authenticated representation letter, if solicitor is not affiliate or headquarter of manufacturing company
Before submission for registration, all quality, efficacy and security information has to be reviewed by the New Molecule Committee.Submission package consists of:FormStability studiesEfficacy and safety information (publications, studies)Labeling textsPatent or licensing documentsOrigin identification and GMP certificate for DS+DPTechnical information for raw materials:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsTechnical information for finished product:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsCopy of manufacturing orders of batches used for stability testsTechnical information for packaging materials:Description and capacity of primary and secondary packaging materialsFor primary packaging: tightness test, results and bibliographic referenceCopy of packaging orders of batches used for stability testsIf the drug product will be manufactured in a country different than Mexico, these additional documents must be included:CPP of originDS+DP GMP certification of origin by a recognized country (apostilled/legalized)Authenticated representation letter, if solicitor is not affiliate or headquarter of manufacturing company
Before submission for registration, all quality, efficacy and security information has to be reviewed by the New Molecule Committee.Submission package consists of:FormStability studiesEfficacy and safety information (publications, studies)Labeling textsPatent or licensing documentsOrigin identification and GMP certificate for DS+DPTechnical information for raw materials:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsTechnical information for finished product:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsCopy of manufacturing orders of batches used for stability testsTechnical information for packaging materials:Description and capacity of primary and secondary packaging materialsFor primary packaging: tightness test, results and bibliographic referenceCopy of packaging orders of batches used for stability testsIf the drug product will be manufactured in a country different than Mexico, these additional documents must be included:CPP of originDS+DP GMP certification of origin by a recognized country (apostilled/legalized)Authenticated representation letter, if solicitor is not affiliate or headquarter of manufacturing company
Before submission for registration, all quality, efficacy and security information has to be reviewed by the New Molecule Committee.Submission package consists of:FormStability studiesEfficacy and safety information (publications, studies)Labeling textsPatent or licensing documentsOrigin identification and GMP certificate for DS+DPTechnical information for raw materials:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsTechnical information for finished product:Monograph, control methods, validation, bibliographic referencesCertificates of analysis, spectra, chromatogramsCopy of manufacturing orders of batches used for stability testsTechnical information for packaging materials:Description and capacity of primary and secondary packaging materialsFor primary packaging: tightness test, results and bibliographic referenceCopy of packaging orders of batches used for stability testsIf the drug product will be manufactured in a country different than Mexico, these additional documents must be included:CPP of originDS+DP GMP certification of origin by a recognized country (apostilled/legalized)Authenticated representation letter, if solicitor is not affiliate or headquarter of manufacturing company
Pesticides, products used in agriculture and drugsSimilar biotherapeutic product
In Mexico the drug registration procedure will depend on the type of product that it is intended to get registered.After document submission, the official timeline for an answer is 6 months. Until last year, the norm was between 1 and 2 years. Last, year, a new option was introduced which contemplates the possibility of having third parties (consultants) previously evaluated and approved by COFEPRIS, do a pre-evaluation of the dossiers, which expedites the posterior revision by COFEPRIS, and at the same times lightens the burden for the evaluators at the health authority, allowing a quickest revision of all submissions.
In Mexico the drug registration procedure will depend on the type of product that it is intended to get registered.After document submission, the official timeline for an answer is 6 months. Until last year, the norm was between 1 and 2 years. Last, year, a new option was introduced which contemplates the possibility of having third parties (consultants) previously evaluated and approved by COFEPRIS, do a pre-evaluation of the dossiers, which expedites the posterior revision by COFEPRIS, and at the same times lightens the burden for the evaluators at the health authority, allowing a quickest revision of all submissions.
Reports for the last two years: manufactured batches, rejected batches, released batches investigated, reprocessed batches, complaints, refunds, market recalls.
Slow and fastacetlylators, depending on the metabolic route the drug can be eliminated faster or more slowly.