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24 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
2. Focus on Middle East & North
Africa Area
25 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
API Internal Market under development
Big Influence by European Multinational
Middle East Access Point
Large state influence in the management of local industry
Algeria
Egypto
Libia
Maroccos
Tunisia
26 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
Pharmaceutical Companies
Sanofi Aventis, Pfizer, Roche, entre otras …
Compañías estatales: Saidal, Digromed y Endimed
Total de compañías productivas: 38
Local Manufacturer
Producción local: 400 MMD
Saidal: 120 MMD
Referencia: Thomson Reuters
27 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
Pros
1991: end of market monopole
Local Production: 22% of the 1400 products registered
60% of the local production are Basic/Generic products &/or dedicated to Hospital
Market dominated by importation
Expected strong growth in demand for medicines for chronic diseases &/or associated with aging of the population (cardiovascular and nervous system)
Important incentives for companies investing in the sector
Big opportunities for Technology Transfer & Licensing
Contras
European Multinational Company are strong player of the local market (GMP!!)
Large state influence in the management of local industry
Margins are set by government between 10% and 20%
Generics Products are NOT si appreciated
The Prohibition of Importation of Pharmaceuticals and Medical Devices Intended for Human Medicine (JORA February 25, 2009) expressly prohibits the import of 359 products and 7 PF MD
Importers must submit a biennial plan investments, according to 2008 legislation
Local recent Resolution to reduce to the minimum required importation of finished product
28 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
http://www.latconsultores.com.ar/novedades
29 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
Pharmaceutical Company
Holding Company for Pharmaceuticals: 50% volumen 30% valor
ACDIMA Group
Multinational: Pfizer, GSK, Novartis, Sanofi Aventis, BMS
EIPICO (5% del mercado)
Big Number of Pharmaceutical Companies (11 Public)
Local Production
Finbished Product Importation: 20% of the market
API Importation : 85%
30 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
Pros
The Biggest Pharmaceutical producer and consumer in MENA Area
Population: over 80 Millions
High diffusion of Generic Products: 50 % of the market
Most pharmaceuticals are imported from Europe and USA, only a small percentage from Asia
Free trade agreement with Mercosur tariffs release in 8 to 10 Years
Contras
The government is pursuing the pharmaceutical self-sufficiency
Resistance to new Products
Large state influence in the management of local industry (30%)
Ban on imports of vitamins, supplements and natural products as a finished product.
Prices set by the Ministry of Health
31 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
Pharmaceutical Companies
Central Pharmacy of Tunisia: hospitals and health structures
Multinational Companies: Sanofi Aventis, UPSA, BMS, Pfizer -mayormente importado o fabricado localmente
Local Companies: SAIPH, ADWYA, TERIAK, SIPHAT, UNIMED, BIOMAGREB, Medis, Pharmaghreb, etc.
Local Production
Mercado: 250 MMD
Importation: 53% del mercado
State influence / participation in the management of local distribution (3 de 46 mayoristas)
32 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
Pros
Market dominated by IMPORTATION
Hospital Market: Annual Tender
Fast negotiations (3 months)
Country that acts as a distribution center for African and Middle Eastern
Tax credits for raw materials and packaging materials
Contras
Patent Protection and recognition of intellectual property
Market oriented to Europe
Tax agreement with the EU for finished product
State Monopole on certain importation (Tender)
Regulatory requirements are becoming very similar to the European (EU GMP!!)
There are plans to limit imports according to the Algerian model
33 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
80%
70%
48%
40%
22% 20% 20%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Egipto Marruecos Tunez Jordania Algeria Arabia Saudita
Emiratos Arabes Unidos
Autosuficiencia Farmaceutica MENA
Limitation of imports
Algeria 2009
Marruecos 2012
Túnez 201?
34 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
Referencia: NOSIS EXI Explorer
2006,5 2007 2007,5 2008 2008,5 2009 2009,5 2010 2010,5
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0,0
1,0
2,0
3,0
4,0
5,0
6,0
2007 2008 2009 2010
Exportaciones Farmaceutico Norte de Africa
Exportaciones en MMD % Variacion Interanual
Argelia 55%Tunez
25%
Marruecos 14%
Resto6%
Distribución de las ExportacionesNorte de Africa por Zonas (08-10)
35 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
3. Evolving Scenario
36 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
From September 1, 2010 shall enter into force the new
Russian law on the marketing of drugs, which affect both
the products of local manufacture, import and
medicaments.
The new law establishes standard procedures for the
certification of drugs intended for sale, and is intended to
standardize the products "made in Russia" to European
standards and ensure greater consumer information.
The characteristics of medicinal products will be exhibited
for sale on an internet portal and certain limits (60 to 210)
were fixed for the execution of clinical trials and completion
of the certification process.
37 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
Minimum SET of Documents required for Sales Finished Products
Delegation legalized (authenticated - Notary) to the "legal person" authorized by the Producer to deals
with registration of the drug
Certificate of free sale (or the certificate of pharmaceutical product) - "APOSTILLED" (Original or
notarized copy).
License for Production (Manufacturing authorization- APOSTILLED - Notarized Copy)
GMP Certificate - Original or the APOSTILLED/Notarized Copy
Certificate of Registration (for the country in which the company produce) with the Company STAMP
Certificate of analysis on the finished product and API, provided with the seal of the company
In case of trademark, a copy of the confirmation of registration of the trademark in the Russian
Federation is needed, with the seal of the company
Information on drug registration in other countries (which countries are registered, for how long),
bears the seal of the company
Summary of Production Process Description, authenticated by the manufacturing company
Full Qualitative and Quantitative Analytical Methods (and QC Controls, with reference to the specific
pharmacopeia)
Stability data on the samples of the drug - at least 3 series, which confirm the stated expiry date of all
types registered in the primary package
38 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
Minimum SET of Docouments required for Sales Finished Products
Chromatograph and Spectrum
Report on the research of the pharmacological (specific), which motivates all the indications for use,
established in product document
Report on the study of toxicity (acute, sub-acute, sub-chronic, chronic)
Report on the study of specific types of action (carcinogenic, mutagenic and teratogenic, embryotoxic,
allergizzazione and properties owned by local irritant and so on.)
Clinical Study Report
Data on the use of the drug in the clinic and the publication after registration (copies of the
publication) (only on the drug, produced by the company)
Bioequivalence data (for tablets, capsules, dry powder for preparation of suspensions)
Information on the effect side in comparison with similar drugs of similar effects
Medical application instructions, samples and packaging
Information on the material used for the manufacture of the drug: Certificates for packaging material
and packaging, which confirm the possibility of medical use of them, certified by the seal of the
company
Samples of internal and external packaging color (original and in Russian)
Standard samples of the active substance, necessary for quality control
Working standards and standards of the drug for the implementation of the required verification of
quality standards of drugs, declared for the state registration
39 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
39
30-09-2010
Algeria
Pharmaceutical, negotiation with USA Comnpanies
The Algerian government is in talks with several U.S.
companies interested in the pharmaceutical
sector. This was declared by the Algerian Minister of
Health, Djamel Ould Abbes, Algeria, stressing that
"wants to build a domestic industry of the
drugs.""Currently, we depend on imported drugs,
especially from Europe - the minister said, quoted by
APS - and our American partners said they were
willing to invest in the country through technology
transfer, training and research. A letter of intent will be
signed today. "
….. Furthermore, there are signs that
local drugmakers are looking to take
advantage of foreign expertise to
enhance their drug-making
capabilities. In February 2010, one of
Algeria's largest drugmakers, Saidal,
strengthened its tie-up with the
Cuban pharmaceutical industry
through an agreement with the
Center for Genetic Engineering and
Biotechnology in Cuba (CIGB) to
develop and manufacture generic
drugs and biotechnology
treatments….
40 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
Protection:
o Each region in which the “demand” is growing will try to
protect LOCAL industries
o Where the local Government could help local industries,
Regulatory Requirements will Grow
o Many Countries (e.g.: MENA Area) start to better support
local Industries
o If an existing plant is renewed &/or a new plant will build, the
standard for Engineering, QC, Production will be European
GMP
o In many Countries instead of IMPORT, even to multinational
Companies, LOCAL Production (&/or Joint Vendor) is start to
be required
41 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
Business Opportunity:
o Generic Product: LICENSING, but with a
European-Like Dossier
o Joint Venture: for some admitted products
o API Export: API will still required, but related to:
o Innovative Product
o WELL documents (HIGH Regulatory
Profile Product)
42 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
SUMMARY
o Emerging Protection force opportunities on High
regulatory requirements &/or innovative products
o Emerging Regulation are build on cGMP or
EU-GMP
o Big Business Opportunity still remain, but to be
competitive even in emerging countries, some key
parameters are mandatory:
o Product Quality
o Product Documents / Registration
o Competitive Price
43 Buenos Aires – ETIF 2010 - MENA & East Europe Regulations – G. Rossi 2010 – rev. 1.0
Gilberto Rossi – CTP Tecnologie di Processo SPA+[39] 348 7216946 – [email protected]
That will be available on http://www.latconsultores.com.ar/novedades.asp
www.ctpsystem.comwww.latconsultores.com.ar
CTP Tecnologie di Processo SPA is a certified company