Brazilian Rules Updating for Pharmaceutical Excipients · 9Resolution‐RDC nº 31, from Aug, 11th...
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1 Brazilian Rules Updating for Pharmaceutical Excipients Jair Calixto May, 9, 10 & 11 th . 1. Sindusfarma: Main Activities SUMMARY 2. Cooperation Program ‐ Sindusfarma/IPEC 3. Brazilian Legislation updating – Pharma Ingredients 2 4. Conclusions
Transcript of Brazilian Rules Updating for Pharmaceutical Excipients · 9Resolution‐RDC nº 31, from Aug, 11th...
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Brazilian Rules Updating for Pharmaceutical
Excipients
Jair Calixto May, 9, 10 & 11th.
1. Sindusfarma: Main Activities
SUMMARY
2. Cooperation Program ‐ Sindusfarma/IPEC
3. Brazilian Legislation updating – Pharma Ingredients
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4. Conclusions
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Sindusfarma is the first business association in the São Paulo State’s pharmaceutical industry Established in April 26 1933
Who is Sindusfarma
pharmaceutical industry. Established in April 26, 1933.
3(Pharmaceutical Products Manufacturers Union in the State of São Paulo)
SINDUSFARMA assembles today more than 130 MEMBERS, which are responsible for 80% of the medicinal drugs manufactured in
BrazilBrazil.
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Estimated Population: Brazil: 193.252.604São Paulo (City): 11.244.369Sã P l St t 41 252 160São Paulo State: 41.252.160
Brazilian Pharmaceutical IndustryCurrent Data 2010
Nº Origem das Companhias US$ (bi) %
280 Nacional 10,484 50,79%
69 Internacional 10,157 49,21%
38 Européias 6,568 31,82%
20 Americanas 3,112 15,08%
Note: Sales to Government are not included Source: IMS Health – november 2010
7 Asiáticas 0,328 1,59%
4 Outras 0,150 0,73%
349 TOTAL 20,641 100%
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BRAZILIAN PHARMACEUTICAL MARKET
2.236 038.0
Sales in R$ (bi) e US$ (bi) & units (bi)Períod: 2003 a 2010
0 6
0.8
1.0
1.2
1.4
1.6
1.8
2.0
10 012.014.016.018.020.022.024.026.028.030.032.034.036.0
Valu
esin
Uni
ts(b
i)
esin
R$
(bi)
& U
S$ (b
i)
Vendas em Reais (R$ bi)Vendas em Dólares (US$ bi)Vendas em Unidades (bi)
0.0
0.2
0.4
0.6
0.02.04.06.08.0
10.0
2003 2004 2005 2006 2007 2008 2009 2010
V
Valu
e
Fonte: IMS HealthElaboração: Sindusfarma / Gerência de Economia
BRAZILIAN PHARMACEUTICAL MARKET
PHARMACEUTICAL PRODUCTS Brazil Exportations & ImportationsPeríod: 1997 to 2011* - In US$ FOB
2 000 000 000
3,000,000,000
4,000,000,000
5,000,000,000
6,000,000,000
7,000,000,000
Em U
S$ F
OB
Exportações (US$ FOB)Importações (US$ FOB)
0
1,000,000,000
2,000,000,000
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011*
Fonte: MDIC/Secex\Sistema AliceElaboração: Sindusfarma / Gerência de Economia
* Janeiro à Fevereiro de 2011
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The attributions of Sindusfarma are provided for in the Brazilian Labor Code Basically includes:
MAIN ACTIVITIES
the Brazilian Labor Code. Basically includes:
the conduction of studies;legal protection and coordination of the category;collaboration with governmental authorities and
other associations towards social solidarity and yserving the country’s national interests.
Services provided for members in different fields include:Newsletters: legislation and regulations applicable to the
h ti l i d t
MAIN ACTIVITIES
pharmaceutical industry;
work groups: to study specific themes of interest for pharma;
holding informative meetings with members to spread and comment on new regulations incorporated to the legislation;
BES (Sindusfarma Employment Exchange): a program available to the professionals;
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Assistency: entities, pharma industries and professionals in regulatory and technical subjects;
MAIN ACTIVITIES
regulatory and technical subjects;
Development: a continuous education annual programs;
Promotion/coordenation: technical workshops, events, plenary meetings and informative bulletins;
To provide technical information by publishing technical books;
Promotion agreements, interchange and cooperation programs with national and international organizations.
Today the PES initiative is made up of 7 different programs comprising the following knowledge areas:
EDUCATIONAL PROGRAMS ‐ PES
I. Training of Machine Operators for the Pharmaceutical Industry; II. Qualification of Visually Impaired People for the Pharmaceutical Industry;III. Pharmaceutical Industry Laws and Registration of Medicinal Drugs; IV. Pharmaceutical Best Practices and Audit Procedures;
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V. DEC – Development and Continuous Education Process;VI. PAP –Support Program for Professional Workers;VII. GST – Work Health and Safety Management.
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AWARDS
1‐ Excelence Labor safety
Is presented to those members who show the most commitment to compliance with the Regulatory Standards
issued by the Labor Ministry, which reflects in the reduction of occupational accidents.
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AWARDS
2‐ Quality Suppliers Awards
The Sindusfarma Quality Suppliers Awards for best pharma suppliers in PM, RM, Equipment, Services is a recognition of the efforts of our members in these
activities.
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TECHNICAL BOOKS
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TECHNICAL BOOKS
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The “Boas Práticas de Higiene, Medicina e Segurança do Trabalho” collection, consisting of five volumes that have already been
TECHNICAL BOOKS
published, out of a total of ten programmed volumes.
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OUR MEMBERS
ABBOTT ACHÉ ALCON AJINOMOTO ALLERGAN ARROW ASTRAZENECA
BAXTER BAYER BIOLAB BOEHRINGER FRESENIUS DAIICHISANKYO
BMS
ELI LILLY PFIZER MEDLEY EUROFARMA
EMS SANOFI TORRENT
SOLVAY ROCHE FERRING MSD MERCK NYCOMEDSOLVAY ROCHE FERRING MSD MERCK NYCOMED
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OUR MEMBERS
Total members today: 130 New members: excipients manufacturers or distributors.
MALLINCKRODT
PHARMADOW
ISP
NOSTRA
MERCK
DOW
Interchange/Cooperation
BP
USPABIQUIF
SINDUSFARMA
EPISPE
IPEC
CEDECAN
FDLI
ACBIO
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Was signed in May, 2009. Objectives:
( ) i f h i f h li
Contract Agreement‐ Sindusfarma/IPEC
(a) increase awareness of the importance of the quality, safety and efficacy of pharmaceutical excipients; (b) promote cooperation between national organizations, government agencies, Brazilian associations and IPEC‐Americas to improve the quality of pharmaceutical excipients; (c) improve transfer and exchange of information between the Parties;the Parties; (d) facilitate the harmonization of pharmaceutical excipients standards; and (e) establish the basis and mechanisms of cooperation between the Parties.
First job: Translation to Portuguese the following guides:
The Joint IPEC – PQG Good Manufacturing Practices Guide for
Contract Agreement‐Sindusfarma/IPEC
The Joint IPEC – PQG Good Manufacturing Practices Guide for Pharmaceutical ExcipientsThe IPEC Good Distribution Practices Guide for
Pharmaceutical Excipients
Second job: Translation to Portuguese the following guides:
l f f f h lQualification of Excipients for Use in PharmaceuticalsThe IPEC Quality Agreement Guide and Template 2009Excipient Information Package (EIP): Template and User Guide
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EXCIPIENTS. Where do they appear today?
Public Consultation‐Will be published in the first semester 2011 ‐ GMP for Excipients
Excipients Legislation Updating
2011 GMP for Excipients.
Resolution‐RDC nº 31, from Aug, 11th 2010‐ Pharmaceutical equivalence studies and Comparative Dissolution Profile.
Resolution RDC nº 71, from Dec, 22th 2009 ‐ Labeling / Packaging rulesPackaging rules
Resolution RDC nº 48, from Oct, 6th 2009 ‐ Post approval rules.
Public Consultation nº ‐ GMP for excipients
Excipients Legislation Updating
Public Consultation nº ..... ‐ GMP for excipients.
First Brazilian initiative about this subject.
Based on text from WHO.
Will not be an obligation, in the first moment .
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RDC nº 31 ‐ BioequivalencePharmaceutical Equivalent definition:
Excipients Legislation Updating
Pharmaceutical Equivalent, definition:
Medicines that contain the same dosage form, same route of administration and same API quantity , i.e., same base salt or ester of the therapeutic molecule, having or not identical excipients, since well established for the intended function.
RDC nº 71 ‐ Labeling
I f i di i i i f API d
Excipients Legislation Updating
In case of contraindication, caution or warnings for APIs and excipients, cartons must contain specific warnings phrases.
Excipients alterations: labels and cartons must contain the information "New Formula" next to the official product name.
Is permitted text insertion with the qualitative description of all excipients in the side of carton, under the red box.
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RDC nº 48 ‐ Post approval rulesMinor Alteration for taste, odour or dyes and some excipients
Excipients Legislation Updating
listed in the resolution:
Comparative dissolution profile Report between previous and new condition, when aplicable;
Validation report of the new analytical method for the FG;Validation report of the new analytical method for the FG;
Stability study report – 1 batch of FG;
Alteration must be implemented only after ANVISA approval.
RDC nº 48 ‐ Post approval rulesModerate alteration (quali/quantitative) for excipients:
Excipients Legislation Updating
Moderate alteration (quali/quantitative) for excipients:
Comparative dissolution profile Report between previous and new condition, when applicable;
Validation report of the new analytical method for the FG;
Stability study report – 1 batch of FG;
Alteration must be implemented only after ANVISA approval.
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RDC nº 48 ‐ Post approval rulesMajor alteration (quali/quantitative) for excipients:
Excipients Legislation Updating
Major alteration (quali/quantitative) for excipients:
Comparative dissolution profile Report between previous and new condition, when applicable;
Validation report of the new analytical method for the FG;
Stability study report – 3 batches of FG;
Technical Report of BE/BA;
INN – Brazil wants to harmonize nomenclature of ExcipientsWork is been conducted by BP.
HARMONIZATION OF NOMENCLATURES
There are rules for vaccines, herbal plants, APIs, others. Not for Excipients.Brazil will adopt electronic registration, then will be imperious to have INN (DCB in Brazil) for Excipients. As does not have rules nomenclature, in certain cases commercial names are adopted, but the committee of INN (DCB – Common Brazilian Denomination) disagree.There is a Brazilian purpose, but others situations are not defined, forThere is a Brazilian purpose, but others situations are not defined, for example: dyes.The possibility to have a work managed by a entity like IPEC (very expert in his field), could be a model. Could be useful for Brazil. Brazil uses as reference CAS number.
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Excipients has an important role in Pharma products
CONCLUSIONS
Excipients legislation: is necessary to improve it.
INN – Brazil wants to harmonize nomenclature of ExcipientsWork is been conducted by BP.
Integration must be done between different associationsIntegration must be done between different associations: IPEC, WHO, FDA, ICH, ANVISA, industries.
Suppliers Qualification: is extremely necessary!
Thank you! Obrigado!Thank you! Obrigado!
Jair [email protected]
Tel. 55‐11‐3897‐9779
