cofepris - Montgomery County Chamber of Commerce

COFEPRIS:
Evolution
March, 2011-August, 2013
September 2013
Pharmaceutical Policy
•  Mexican pharmaceutical policy is committed to increase market access
to a well-supplied drug market that offers innovative medicines at low
prices. To comply with this commitment, this policy rests on 4
fundamental pillars:
1.  A regulatory agency that guarantees safety, quality, and
efficacy of all drugs.
2.  A reliable scheme to authorize sanitary registrations.
3.  The removal of barriers to market entry for safe and high
quality products.
4.  The harmonization of the sanitary agency regulations with best
international practices.
Pillar 1. Backlog reduction
3 The issuance of 16,673 sanitary registrations from March 2011 to July 2013, represents a market value
close to 2 billion dollars, and has a growth rate of 10,870% relative to 2010. Progress has been as
follows:
Issuance of 570 sanitary registrations
per month, on average in the period
March, 2011- July, 2013
18,000
Registros emitidos (acumulado)
16,000
13,873
13,344 13,700
14,000
12,000
10,563
15,100
14,384 14,657
16,453 16,673
15,602 16,017
11,900
11,312 11,618
10,000
7,419
8,000
6,000
4,000
2,000
152
0
2010
2011
Jun-12 Jul-12 Aug-12 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 Jul-13
•  A total of 6,110 sanitary registrations have been issued from June 2012 to July 2013. This
improvement implies an average of 470 monthly registrations. The issuance of sanitary
registrations will continue growing given that COFEPRIS regulates 10% of GDP.
Health Supplies
Simplified
Vaccine
Liberation
•  The guidelines for the scheme were
published in the Official Gazette of the
Federation (DOF) on June 1st, 2011.
•  The new scheme implies a 2-month
waiting time reduction.
•  The maximum allowed response time
was reduced from three to only one
month.
5 Benefits of Authorized Third Parties
Prórroga
Registro
Average processing time for filings of drug products (months)
Modificación
• 
Third Parties issue a “Pre-dictamination” certificate, which must be submitted together with the
complete paperwork when filing for a New Registration, an Extension or a Modification to an
existent Registration to Cofepris.
The “Pre-dictamination” certificate of Third Parties allow to reduce signifcantly the processing
time of each individual filing. For example, in the case of new registrations the processing time was
reduced by an average of approximately 2 years.
Type of filing
• 
Trámite COFEPRIS
30
Trámite con Pre-dictamen
4.5
Trámite COFEPRIS
6
Trámite con Pre-dictamen
3.75
2
Trámite COFEPRIS
0.5
Trámite con Pre-dictamen
0
5
10
15
Months
20
25
30
6 Authorized Third Parties
•  There are 10 Authorized Third Party Companies currently in operation and 365 products have
been authorized in an average of less than 20 days.
•  The following table shows the type of procedure, the total number of filings submitted and its
composition between approved and in process.
Filings submitted with Pre-dictamination of
Authorized Third Parties
Medical
Devices
Procedure
Number of
Filings
In process
Information
pending
Approved
New Registration
213
20
58
135
Extensions
38
4
5
29
Modification
174
27
10
137
New Registration
45
9
16
20
Extensions
3
0
2
1
Modification
57
5
9
43
530
65
100
365
Medicines
Total
7 Pillar 2. Legal Framework Improvement to
Eliminate Market Distorsions
8 The introduction of generic medicines to the pharmaceutical market have followed this pattern:
Package number
New registrations
Date introduced
1st
31
October 5, 2011
2nd
38
November 16, 2011
3rd
66
December 13, 2011
4th
12
February 16, 2012
5th
7
May 2012
6th
15
July 30, 2012
7th
12
October 5, 2012
8th
33
April 4, 2013
9th
19
July, 2013
These medicines are used to treat the following diseases:
Diabetes (type 2)
Prostate cancer
Anesthesia used during surgical procedures
High cholesterol
Erectile disfunction
Osteoporosis and other bone diseases
Several types of Cancer
Ovarian cancer and lung cancer
Breast cancer
High blood pressure and heart failure
Respiratory diseases such as asthma
Herpes Simplex and Herpes Zoster
Schizophrenia
Cardiovascular diseases
Alzheimer's Disease
28 active substances authorized with 233 sanitary registrations corresponding to 71% of Mexican mortality.
Active
Substance
Innovator’s
Brand
Authorization
Date
Therapeutic Use
Accumulated Saving in 4
years (millions of pesos)
Registrations
Atorvastatina
Lipitor
Oct 5
Lowers blood cholesterol
Cardiovascular diseases.
$1,655
10
Gemcitabina
Gemzar
Oct 5
Pancreatic Cancer
$249
12
Pioglitazona
Zactos
Oct 5
Treatment for diabetes mellitus
$760
15
Bicalutamida
Casodex
Nov 16
Treatment for prostate cancer
$157
4
Olanzapina
Zyprexa
Nov 16
Treatment for schizophrenia
$1,091
12
Sildenafil
Viagra
Nov 16
Treatment for erectile disfunction
$1,512
22
Valsartán
Diovan
Nov 16
$628
6
Docetaxel
Taxotere
Dec 13
$570
13
Montelukast
Singulair
Dec 13
$1,479
38
Clopidogrel
Iscover, Plavix
Dec 13
Antiplatelet to prevent blood clots
$1,692
20
Cisatracurio
Ácido
Zoledrónico
Nimbex
Dec 13
$301
2
Zometa
Feb 16
Anesthetic
Treatment for osteoporosis and
Paget’s bone disease
$200
3
Anastrozol
Arimidex
Feb 16
Treatment for breast cancer
$202
11
Valaciclovir
Rapivir
Feb 16
Treatment for Herpes Simplex and
Herpes Zoster
$95
2
Treatment for high blood pressure
and heart failure
Treatment for several types of
cancer
Treatment for respiratory diseases
such as asthma
Active
Substance
Innovator’s
Brand
Authorization
Date
Therapeutic Use
Accumulated Saving in 4 years
(millions of pesos)
Registrations
Quetiapina
Seroquel
May
Treatment for schizophrenia and
bipolar disorder
$89
4
Losartán
Cozaar
May
Antihypertensive
$840
6
Donepecilo
Donepezil
May
Treatment for Alzheimer's Disease
$171
3
Cefepima
Maxipime
Jul 30
$139
4
Escitalopram
Lexapro
Jul 30
Treatment for respiratory infections
Treatment for depression and
anxiety
$618
10
Micofenolato
de Mofetilo
Cellcept
Jul 30
Treatment for organ transplant
$579
5
Imiquimod
Aldara
Oct
Treatment for warts, keratosis and
carcinoma
$85
5
Lamivudina
3TC
Oct
Treatment for Hepatitis B and HIV
$58
8
Abacavir
Ziagenavir
Oct
$143
2
Mometasona
Supridier
Oct
Treatment for HIV-1 and HIV-2
Treatment for allergic rhinitis,
sinusitis and nasal polyposis
$512
2
Irbersartán
Aprovel
Oct
Antihypertensive
$840
3
Telmisartán
Micardis
April 4
Antihypertensive
$2,675
6
Meropenem
Meronem IV
April 4
Antibiotic
$1,339
1
Pregabalina
Lyrica
July
Treatment to reduce neuropathic pain
$353
4
Total
28
Substances
9
Packages
--
$19,032
(1.52 billion dollars)
233
• 
The average price decrease for the private market has been 67%. Average
price of(Promedio)
innovator
Precio
de Innovador
$7,000
Average
price (Promedio)
of generics
Precio
de Genérico
Decrease
of 46.3% in
price
$6,000
Decrease
of 61% in
price
Pesos
$5,000
$4,000
Decrease
of 88.3% in
price
Decrease
of 65.3% in
price
Decrease
of 83.1% in
price
Decrease
of 52.7% in
price
Decrease
of 73.2%
in price
Decrease of
66.7% in
price
$3,000
$2,000
Decrease
of 71.8%
in price
Decrease
of 72.2% in
price
Decrease of
72.1% in
price
Decrease
of 79% in
price
Decrease of
75.7% in
price
Decrease
of 52.8% in
price
Average
decrease in
price: $907
(Decrease of
67%) in
price
Decrease
of 52.8% in
price
Decrease
of 59.2% in
price
$1,000
$0
Source: Cofepris (2013).
12 •  Analyzing the public auctions by the Mexican Institute of Social Security regarding the
liberated active substances, we observed an average price reduction of generics of $428,
(35 USD) which represents an average reduction of 67.8% for the population.
$2,500.00
Decrease of
5% in price
$2,000.00
Decrease
of 91.4%
in price
Pesos
$1,500.00
$1,000.00
Decrease
of 89.7%
in price
$500.00
$-
Decrease
of 82.4%
in price
Decrease
of 90.8%
in price
Average IMSS
Decrease
of 94.1%
in price
Decrease
of 42.9%
in price
Precio Promedio en
public auction
Licitaciones
Públicas
price
in
2011
IMSS 2011
Decrease
of 45.8%
in price
Average
IMSSen
Precio
Promedio
public auction
Licitaciones
Públicas
price
in
2012
IMSS 2012
Average
decrease in
price: $428.11
(Decrease of
67.75% in
price)
13 Source: IMSS (2011, 2012) and Cofepris (2012).
•  A total of 28 active substances have been released from October 2011 to
June 2013. This corresponds to 233 new registrations of generic
medications addressing 71% of Mexico´s mortality causes :
Number of
Packages
Released
Substances
New Drug Options
Accumulated savings
during the following
four years
(billion dollars)
9
28
233
1.52
Aditional
Patients
1,081,962
14 Legal reforms regarding biotechnological medicines
Comprehensive Legal Framework for
Biotechnological Medicines
• 
This new biotechnology regulation places Mexico´s
legal framework among the most modern and
forward looking legislation currently operating in the
European Union and the United States.
• 
In Mexico, 35% of the new applications for innovative
pharmaceutical sanitary registrations are related to
molecules derived from biotechonology processes,
especially in fields related to cancer and neurological
diseases. 1.  2009. Enactment of the Biotechnological
Medicines Act.
2.  October 18, 2011. Issuance of the
Administrative Regulations regarding
Biotechnology Medicines by the
President. Enactment on April 16,
2012.
3.  September 20, 2012. Issuance of
specific requisites to produce and
commercialize biological medicines by
COFEPRIS.
15 Incentives for New Molecules
•  From 2011 to 2013, 88 sanitary registrations for innovative drugs
corresponding to 20 different therapeutic groups were granted. This new
drugs address 54% of the causes of death in the Mexican population.
•  The average annual cost of the treatments associated to these drugs is 8
thousand dollars while the market value of the registrations is estimated at
around 9.3 million dollars.
Number of
Sanitary
Registrations
Therapeutic
Classes
Average Annual
cost of treatments
(thousands of dollars)
88
20
8
Deaths associated to
Market value of
Therapeutic classes as emitted registries
(%) of total deaths
(millions of dollars)
54%
9.3
16 Equivalence Agreement on New Molecules
•  In the past, new molecules in Mexico took an average of 360 days to
enter the market.
•  The agreement on new molecules represented an effort to strengthen
the access of Mexican families to medicines, reduce health care costs
and encourage innovation in three key areas:
1.  Foster projects of innovation in Mexico.
2.  Strengthen the entry of molecules from other countries to the
Mexican market.
3.  Mexico becoming a first country to market an innovative drug.
17 The Equivalence Agreement for new molecules is implemented through:
1. 
Framework to foster projects of innovation in Mexico
Before the agreement, research projects of domestic firms were not supported by a regulatory framework. As a
consequence there were not any incentives for innovation. The new agreement considers the following:
• 
The creation of a Subcommittee to Evaluate Developing Products within the Committee for New Molecules.
• 
The Subcommittee together with the corresponding Mexican firm will conduct the research process of the new
drug.
• 
Once the process is concluded, the approval and registration is granted within 60 days.
2. 
Equivalence Agreements with national regulatory agencies of Australia, Canada, European Union,
Switzerland and United States.
Before the Equivalence agreements, COFEPRIS had to repeat the analysis these agencies had done. This
situation delayed the access of new medicines to the Mexican market. The new agreement considers:
– 
Recognition of Sanitary Registration of New Molecules from these agencies.
– 
Along with the registration, COFEPRIS tests the quality, safety and efficacy of the products.
– 
Provided the results of tests are positive, COFEPRIS issues a resolution within 60 days after presenting the
18 3. 
Reform to Promote the Clinical Research in Mexico
In the past, Laboratories had to present a sale certificate of other country in order to commercialize a medicine in
Mexico. Laboratories had no incentives for clinical innovation in Mexico since they had to introduce medicines in
other country before they could sell in Mexico. Mexico could not be their first market.
– 
On October 9, 2012, a regulatory reform was introduce replacing the sale certificate of another contry, with a
report of clinical research in Mexican population.
– 
As a result, Mexico could be the first market for innovative drugs, encouraging clinical resarch in the country.
– 
The above has been possible because COFEPRIS has been certified by PAHO as a «National Regulatory
Agency of Regional Reference» Certification the PAHO with regard to vaccines and medicines.
• 
As a result of this Agreement, the days to authorize a registration decreased from about 360 days to 60, implying a
decrease in the regulatory burden of about 82% of the waiting days.
Decrease in Days to Process Registrations with the Agreement
60 days
AEMI
Molecules from Abroad
360 days
Before the agreement
MNFN
60 days
New Molecules Manufactured in Mexico
Before the agreement
240 days
0
50
100
150
200
Number of Days
250
300
350
400
19 •  The new regulation provides a framework by which Mexico became the
fastest country to authorize the marketing for new molecules while, at the
same time, ensures the eficacy, security and quality of medicines.
•  The main goal: Improve the health of Mexican population.
Days to Grant Registration for Innovative Drugs
360
300
300
290
270
220
203
200
180
180
150
120
120
100
90
60
éxico (con acuerdos)
Brasil
India
Argentina
Reino Unido
Estados Unidos
China
Australia
España
Singapur
Arabia Saudita
Canadá
0
México (antes)
Number of Days
400
20 Pillar 3. Regulatory Reform and Deregulation
21 Removal of the requirements to have a
manufacturing plant on national soil
q  In 2011 the Mexican Government removed the requisite to have a manufacturing plant in
Mexico to market a medicine
q  Approval of the first 218 registrations in this category which had been requested more than 10
months before.
Impact:
BENEFITS:
•  Increase the supply of pharmaceuticals.
•  Availability of new molecules for research and
development.
Investment above 100 million dollars
in the next five years.
100% increase in the workforce of the
firms involved.
22
Issuance of Registrations through Equivalence Agreements
•  The scheme is based upon the recognition of the registrations issued by FDA,
Health Canada, and Japan for medical devices of any class and COFEPRIS will
issue the corresponding registration in a maximum period of 30 working days.
Received Applications
Market Value of the applications
Reduction in the Regulatory Burden
Approved Applications
The Incoming Applications Correspond to:
(Medical Devices)
2,846
245.1 million dollars in the Mexican market
(1.5 million pesos each registration).
40%
68% from FDA
30% from Health Canada
2% from Japan
34% Class 1
39% Class 2
27% Class 3
•  To this date 2,024 sanitary registrations have been approved by COFEPRIS.
Regulation on advertisement of «Miracle Health Scams»
•  On January 18, 2012 the Health Law was amended aiming to prevent and stop misleading
advertisement of fake miracle cures.
70
60
60
58
52
50
47
45
49
CANIPEC agreement
47
41
40
38
PROFECO agreement
March 13, 2012.
40
31 30
Copy Advice´s starts
30
20
Orders suspension and refusal of advertising
Publication
10
Preparation and consensus reforms RLGSMP
Forfeiture
6 to CV Directo and Innova
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Mar-12
Apr-12
May-12
Jun-12
Jul-12
Aug-12
Sep-12
Oct-12
Nov-12
Dec-12
Jan-13
Feb-13
Mar-13
Apr-13
May-13
Jun-13
Entry into force
0
In 12 months, with the implementation of the comprehensive strategy by COFEPRIS, the advertisement of
unauthorized products was reduced in 100%, from 58-0 products with media appearances.
Jul-13
Feb-12
Jan-12
Dec-11
Nov-11
Oct-11
Sep-11
Aug-11
Jul-11
Jun-11
May-11
Apr-11
Mar-11
Feb-11
0
24 From January 2011 to March 2012, media appearances of such “miracle” cures was
reduced about 87.4%. In July, 2013 there were no media appearances.
4,000
Advertisement per month
(January 2011 - Julio 2013)
3,676
3,500
2,970
2,9292,950
3,000
2,571
2,468
2,222
2,012
2,500
2,000
2,307
2,212
2,133
1,973
1,903
1,386
1,500
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Aug-12
Sep-12
Oct-12
Nov-12
Dec-12
Jan-13
Feb-13
Mar-13
Apr-13
May-13
Jun-13
Jul-13
Apr-12
Mar-12
Feb-12
Jan-12
Dec-11
Nov-11
Oct-11
Sep-11
Aug-11
Jul-11
Jun-11
May-11
Apr-11
Mar-11
Feb-11
0
Jul-12
175
Jun-12
500
May-12
1,000
25 • 
• 
• 
The strategy of sanitary surveillance includes forfeiture of tobacco, alcohol, clenbuterol, «miracle»
products and health supplies.
From 2011 to 2013, irregular medicines were seized in 215 establishments and a total of 43
slaughterhouses have been closed.
With this strategy COFEPRIS has increased its efficacy in 50,870% during 2011-2013 compared with
2010, on average.
Sanitary surveillance:
Inspections and forfeiture of products (2010-2013)
Product
2010
2011-2013
Growth rate
Tobacco
40,000 cigarettes
156,023,161 cigarettes;
630 Kg.
400,000%
Alcohol
87,175 liters
377,745 liters
333%
Clenbuterol
0 closed slaughterhouses
43 closed slaughterhouses
-
«Miracle» products
40,000 units
Health Supplies*
2.5 tons.
1,453,054 units;
117,215.4 Kg.
136.7 tons.;
55,696 units (medicines);
1’224,765 pieces (med. Devices)
Source: COFEPRIS (2013). Includes data from 2010 to July, 2013.
* On medicines comparison is between 2009 and the sum of inspections from 2010 to 2013.
Average growth rate
50,870%
3,533%
5,368%
26 • 
During 2010, COFEPRIS seized only 40,000 fake «miracle» products compared to 1,453,054
products seized from January 2011 to July 2013, implying a 3,533% increase compared to the 2010
figure. The latter resulted from the inspection of 1,668 sites.
Forfeiture of «Miracle» Products, 2010-2013*
Type of site
Points of sale (national)
Laboratories CAPSLIM, Warehouse CV Directo**, Marcas de
Renombre, S. A. de C. V., Gala Crom Tablets, Nutrisa***,
Drug stores and Department stores****
Total
Growth rate of forfeitures
Seized products
Date
40,000
2010
1,453,054
January, 2011 – July, 2013
1,493,054
3,533%
* Data generated from January, 2011 to July, 2013.
** Seized products: CELUNUVEL, ONE WEEK ULTRA, COLD HEAT EXTREME, COLD HEAT, MALUNGAY, SKINY SHOT y otras marcas.
*** Seized : 26 boxes of 30 units (120 capsules each) plus 11 units of 120 boxes each.
**** Products seized: Rejuvital, Xiomega 3, Nopaesbelt, Xenadrine, Demograss, FatBlok, Redu-C2, Lipozene, New Body Slim, Jugo de Aloe Vera, Bonfibra, Emergen-C, Alcachofa,
Vital Zen, Ajovit, Gastrisin, Diabetal, Pulmosin, Vari-C, Artri-R, Fortex y Prostasin, Chaparro Amargo, Ginkgo Biloba, Cardiocare, Force-C, Bronkitose, Relaxil, Hierbas Suecas,
Alcachofa Diet, Stress Care, Zinestress, Gastrinat, Colesstin, Colesterol 7 días pronat pack, Canecroplan, Dieters Drink, Siluet Control, Body Slim, Redu Si, Wereke, Uña de
Gato y Hierba de San Juan. Also, 8 advertisement posters were seized during June, 2012 and 61,865 units of advertisement material were seized during February, 2013.
27 New facilities for COFEPRIS
Previous Scheme
New Scheme
Variation
27 ventanillas
60 ventanillas
33 Ventanillas (+122.2%)
31 simultaneous users
60 simultaneous users
29 users (+93%)
45 waiting minutes
25 waiting minutes
-20 minutes (-44%)
600 daily procedures
1,200 daily procedures
600 procedures (+100%)
25,000 files
90,000 files
60,000 files (+260%)
Previous
New
28 Pillar 4. International Harmonization
29 STEP 1
Meeting with the PAHO representatives regarding future collaboration and a
cooperation agreement.
June 8, 2011
STEP 2
Participation in the VI Panamerican Conference for the Pharmaceutical
Regulation Harmonization, Brasilia, Brazil.
July 6-8, 2011
STEP 3
Formal audit in COFEPRIS with the collaboration of personnel from PAHO
August 4-5, 2011
STEP 4
Informal audit and consulting by KAIZEN Consulting
November 7-16,
2011
STEP 5
Informal audit in COFEPRIS with the collaboration of personnel from PAHO
December 12-15,
2011
STEP 6
Informal audit and consulting by KAIZEN Consulting
Feb 27–March 2,
2012
STEP 7
Informal Internal Audit by COFEPRIS´ personnel
March 20-27, 2012
STEP 8
Informal audit in COFEPRIS with the collaboration of personnel from PAHO
April 9-13, 2012
STEP 9
Formal audit in COFEPRIS
June 18 – 23, 2012
SUMMARY OF SCORES WITH CRITICAL INDICATORS in %
Critical Indicators
NI
EI
PI
I
Level
Regulatory System
0
0
0
100
IV
Sanitary Authorization
100
IV
Licensing
100
IV
Market Surveillance
100
IV
Pharmacovigilance
100
IV
Clinical Trials
100
IV
Inspections
100
IV
National Laboratory
100
IV
Vaccine Liberation
100
IV
TOTAL
100
IV
COFEPRIS is now a National Regulatory Agency of Regional Reference
* This certification has to be renewed in 2014.
Recognition of sanitary registrations abroad
Pacific Alliance
•  On June 20, 2013 the Interagency Agreement between Sanitary Agencies of the Members of the
Pacific Alliance was signed in Lima, Peru. The objective is to accelerate the issue of sanitary registrations
to medicines in Chile, Colombia, Mexico and Peru.
•  As a consequence, COFEPRIS and INVIMA recognize sanitary registrations issued by both agencies. The
Mexican pharmaceutical industry will now have access to a market with 47 million additional patients.
•  The Agreement also requests to the sanitary agencies of Chile and Peru to be certified according to PAHO
standards in order to benefit from the negotiation.
Central America
•  On July, 2013 COFEPRIS will sign an Agreement of Cooperation and Confidentiality with the sanitary agency
of Costa Rica in order to provide technical support and establish a mechanism of rapid access to medicines
with registration issued by COFEPRIS. The Mexican pharmaceutical industry will have access to a market
with 5 million additional patients.
It is expected that the sanitary registration issued by COFEPRIS doubles its coverage and reaches more
than 235 million additional patients by 2014.
Country
Colombia
Peru
Chile
Population, 2011
(in millions)
47
30
17
Source: World Bank (2012).
Ecuador &
Costa Rica
El Salvador
21
5
Panamá
Total
3.5
123.5
32 Recognition by the WHO of COFEPRIS for vaccines
COFEPRIS began the process of recognition regarding vaccines which is granted by the WHO:
1)  With the process that led to the recognition as a «national regulatory agency of regional reference» regarding
medicines and vaccines, COFEPRIS has completed 80% of the WHO evaluation procedure regarding
vaccines.
2)  Seven critical steps have been defined in order to obtain the recognition of the WHO:
STEP 1
Reunion with representatives of the WHO about future colaboration and
execution of the cooperation agreement.
FEBRUARY, 2013
STEP 2
Harmonization of procedure and evaluation tools WHO-PAHO.
FEBRUARY
STEP 3
Informal review in COFEPRIS with colaboration of WHO staff.
APRIL
STEP 4
Internal auditing on the fulfillment of the evaluation tool and on the quality
management system
MAY – JUNE
STEP 5
Revision by the PAHO to assure level IV of COFEPRIS as a «national
regulatory agency of regional reference» regarding medicines and vaccines.
AUGUST
STEP 6
Certification of Institutional Quality Management System based on international
norm ISO 9001:2008.
NOVEMBER
STEP 7
Formal auditing to COFEPRIS by WHO regarding vaccines.
DECEMBER, 2013
Initiation of PICS membership process
COFEPRIS formally applied for pre-accession to the Pharmaceutical
Inspection Cooperation Scheme (PICS) in 2013
•  COFEPRIS began the process for pre-accession to the PICS to harmonize
the inspection standards for GMPs according to the best international
practices.
•  Membership in the PICS will represent benefits to both, the sanitary agency
and the industry in terms of avoiding duplicity of inspections. This will be
achieved by mutual recognition of GMP certificates among all 44 (countries)
members of the scheme.
•  Competitiveness of the domestic industry will be favored by the reduction of
barriers to the entry of Mexican exports to international markets.
•  Assesment of the organization is expected by the end 2013.
COFEPRIS:
Evolution
March, 2011-September, 2013
September 2013