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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

2. Focus on Middle East & North Africa Area · Focus on Middle East & North Africa Area. ... Exportaciones Farmaceutico Norte de Africa Exportaciones en MMD % Variacion Interanual

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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