Gamma Sterilization of Pharmaceuticals—A Review of the Irradiation of Excipients, Active Pharmaceutical Ingredients, and Final Drug Product Formulations

1. Fatima Hasanain, 
2. Katharina Guenther, 
3. Wayne M. Mullett and
4. Emily Craven

+Author Affiliations

1. Nordion, Ottawa, Ontario, Canada

1. Corresponding Author: Nordion, 447 March Road, Ottawa, Ontario, Canada K2K 1X8. Tel: +1 613 592 3400 ext 2044, E-mail: Emily.Craven@nordion.com

1. All authors contributed equally to this paper and are all considered as first authors.

Abstract

Sterilization by gamma irradiation has shown a strong applicability for a wide range of pharmaceutical products. Due to the requirement for terminal sterilization where possible in the pharmaceutical industry, gamma sterilization has proven itself to be an effective method as indicated by its acceptance in the European Pharmacopeia and the United States Pharmacopeia (). Some of the advantages of gamma over competitive procedures include high penetration power, isothermal character (small temperature rise), and no residues. It also provides a better assurance of product sterility than aseptic processing, as well as lower validation demands. Gamma irradiation is capable of killing microorganisms by breaking their chemical bonds, producing free radicals that attack the nucleic acid of the microorganism. Sterility by gamma irradiation is achieved mainly by the alteration of nucleic acid and preventing the cellular division.

This review focuses on the extensive application of gamma sterilization to a wide range of pharmaceutical components including active pharmaceutical ingredients, excipients, final drug products, and combination drug–medical devices. A summary of the published literature for each class of pharmaceutical compound or product is presented. The irradiation conditions and various quality control characterization methodologies that were used to determine final product quality are included, in addition to a summary of the investigational outcomes. Based on this extensive literature review and in combination with regulatory guidelines and other published best practices, a decision tree for implementation of gamma irradiation for pharmaceutical products is established. This flow chart further facilitates the implementation of gamma irradiation in the pharmaceutical development process. The summary therefore provides a useful reference to the application and versatility of gamma irradiation for pharmaceutical sterilization.

LAY ABSTRACT: Many pharmaceutical products require sterilization to ensure their safe and effective use. Sterility is therefore a critical quality attribute and is essential for direct injection products. Due to the requirement for terminal sterilization, where possible in the pharmaceutical industry sterilization by gamma irradiation has been commonly used as an effective method to sterilize pharmaceutical products as indicated by its acceptance in the European Pharmacopeia. Gamma sterilization is a very attractive terminal sterilization method in view of its ability to attain 10⁻⁶ probability of microbial survival without excessive heating of the product or exposure to toxic chemicals. However, radiation compatibility of a product is one of the first aspects to evaluate when considering gamma sterilization. Gamma radiation consists of high-energy photons that result in the generation of free radicals and the subsequent ionization of chemical bonds, leading to cleavage of DNA in microorganisms and their subsequent inactivation. This can result in a loss of active pharmaceutical ingredient potency, the creation of radiolysis by-products, a reduction of the molecular weight of polymer excipients, and influence drug release from the final product. There are several strategies for mitigating degradation effects, including optimization of the irradiation dose and conditions. This review will serve to highlight the extensive application of gamma sterilization to a broad spectrum of pharmaceutical components including active pharmaceutical ingredients, excipients, final drug products, and combination drug–medical devices.

web source:



Gamma Sterilization of Pharmaceuticals—A Review of the Irradiation of Excipients, Active Pharmaceutical Ingredients, and Final Drug Product Formulations

Anvisa veta princípios farmacêuticos da chinesa Shenyang - Paraná-Online - Paranaense como você

Anvisa veta princípios farmacêuticos da chinesa Shenyang - Paraná-Online - Paranaense como você

US FDA looks to increase domestic, foreign drug manufacturer inspections

By Zachary Brennan , 17-Mar-2014

US FDA looks to increase domestic, foreign inspections

Related tags: FDA, Inspections, Budget

Related topics: Regulatory & Safety, QA/QC, APIs (active pharmaceutical ingredients), Regulations

The number of foreign inspections by the US FDA is expected to grow at a faster rate in FY 2015 than the increase in domestic inspections.

Related news:

Obama’s FY2014 Budget Request Aims to Increase Foreign Manufacturer Inspections

US FDA poised to up China inspections after favourable FY14 budget

Top manufacturers seek clarity on delaying, denying FDA inspections

Foreign Generic Drug, API Manufacturers Hit Hardest by GDUFA Fees

Regis Technologies aces recent FDA inspections

The inspection numbers were detailed in the HHS budget request for 2015, which notes that overseas inspections are expected to rise from 827 inspections to 999, while domestic facility inspections is only going to rise from 1,851 to 1,856.

The FDA inventory of high-risk establishments “is dynamic and subject to change,” HHS said. For example, “firms go out of business, new high-risk firms enter the market, or the definition of high risk evolves based on new information on hazards,” the agency said.

FDA has made inspecting high-risk domestic and foreign firms a priority, though high-risk establishment inspection frequencies currently “vary depending on the products produced and the nature of the establishment. Inspection priorities may be based on a firm’s compliance history or sample results.”

In 2013, the agency set a target of inspecting 750 high-risk facilities and in reality inspected 808. Field investigators inspected 443 domestic high-risk drug establishments and 365 high-risk foreign drug establishments. As a result of these foreign inspections, 43 Good Manufacturing Practices (GMP) based warning letters were issued.

The FDA also recently teamed with the EMA on generic site inspections , while back in October industry sought more clarity on how to delay or deny inspections.

The agency said it “will continue conducting for-cause inspections in response to adverse event reports, product quality complaints, and state requests.”

The FY 2015 Budget request also seeks additional resources to conduct additional proactive inspections of high-risk human drug compounding pharmacies, as well as follow-up inspections of pharmacies identified as needing to take corrective actions during previous inspections.

This content is copyright protected

However, if you would like to share the information in this article, you may use the headline, summary and link below:

US FDA looks to increase domestic, foreign drug manufacturer inspections

By Zachary Brennan, 17-Mar-2014

The number of foreign inspections by the US FDA is expected to grow at a faster rate in FY 2015 than the increase in domestic inspections.

http://www.in-pharmatechnologist.com/Product-Categories/APIs-active-pharmaceutical-ingredients/US-FDA-looks-to-increase-domestic-foreign-drug-manufacturer-inspections

Copyright - Unless otherwise stated all contents of this web site are © 2014 - William Reed Business Media SAS - All Rights Reserved - Full details for the use of materials on this site can be found in the Terms & Conditions

US FDA looks to increase domestic, foreign drug manufacturer inspections

Reckitt Benckiser compra lubrificantes KY, da J&J - DIKAJOB

Recentemente, companhia trouxe para mercado brasileiro a marca de preservativos Durex

Daniela Barbosa, de 

Divulgação/J&J

Gel lubrificante KY, marca de J&J foi comprada pela Reckitt Benckiser

São Paulo - A Reckitt Benckiser, dona da linha de produtos de limpeza Veja e Vanish no Brasil, anunciou a compra da marca de lubrificantes KY, da Johnson & Johnson, nesta segunda-feira,

O valor da aquisição não foi revelado pelas companhias.   

A Reckitt já é dona da marca de preservativos Durex, que recentemente chegou ao mercado brasileiro, e com o lubrificante KY, a companhia pretende criar um portfólio mais completo de produtos voltados para o sexo.

Segundo a companhia, em 2013, as vendas do KY somaram mais de 100 milhões de dólares.

Fonte: Web

Reckitt Benckiser compra lubrificantes KY, da J&J - DIKAJOB

Microbiological Testing & Contamination Control - Contract Pharma

An opinion on the microbial limit test with reference to harmonization.

By Daniel L. Prince, Ph. D., Christopher J. Waskewich, M.S., Kristah J. Kohan, B.S. and Danina G. Rinaldi, B.S. , Gibraltar Laboratories, Inc.

     

Related Features

• Contract Manufacturing: Challenges in a Changing Landscape
• Solid Dosage Outsourcing Trends
• Outsourcing & Lean Manufacturing: Product Quality & Waste Elimination
• Packaging Equipment & Trends

Contamination control for a non-sterile drug was first highlighted by Professor Kallings¹ in Sweden in 1965. He detected strains ofSalmonella in an oral drug, Thyroidinum, USP, a dry thyroid powder from domestic animals. At this time there were no microbial specifications for non-sterile drugs or cosmetics. Soon thereafter, bacteriologists from the USP, FDA and the pharmaceutical industry fashioned a ground-breaking protocol: the microbial limit test. The USP XVIII² microbial limit test was used internationally for 38 years until 2009, when it was harmonized by an international committee called the Pharmacopeial Discussion Group.

The harmonized test first appeared in 2009 as two chapters dealing with enumeration and specified organisms USP <61> and USP <62>, respectively³. USP <62> is substantially different from the previous non-harmonized test; these changes are the subject of this article. The procedures in preparing the sample for testing, method suitability and growth promotion are an improvement. We also believe that elimination of the selective media is of unproven value and potentially error-prone. A case-study is presented withSalmonellae and E. coli on the shift from classical microbiology techniques to polymerase chain reaction [PCR].

Three stages of the Microbial Limits Test
Stage I
Organisms – Specified bacteria are chosen on the basis of potential infectivity by non-parenteral routes, especially the oral, topical, rectal, vaginal, nasal and inhalation routes. Products that may be administered by these routes and their microbiological quality requirements are listed in USP <1111>⁴. This includes components and raw materials. The pre-harmonized methods consisted of Salmonella, Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa. The danger that these organisms pose relates to five things:

1 their survivability in low water activity and/or nutrition-free product,
2 their susceptibility or multiplicity of infection,
3 host susceptibility,
4 portal of entry into the human body and
5 their indication of Good Manufacturing Process deficiencies during manufacturing⁵.

Culture and enrichment media – Directions include the name, incubation conditions, media and chemical composition of culture media recommended to propagate the organism to recovery (elution) from the product and for challenging the media for growth promotion and “method suitability.” Selective and differential media for subculturing from elution (enrichment) fluids are prepared and challenged to verify diagnostic capability.

Stage II
Isolation – Test samples in 1 or 10 gram amounts are inoculated into appropriate specialized enrichment media (see later) and incubated for a stated period of time and temperature. They are then streaked to selective/differential media and observed for growth (present/absent). The presence of pigment or other diagnostic colonial feature or reaction in the agar plate is noted and recorded. A notation of either negative or presumptive isolation is made.

Stage III
Identification – In the non-harmonized methods, presumptive subcultures from the above isolation plates are inoculated to more than one specified diagnostic test and observed for typical reactions, as shown in Table 2. Conclusions are rendered as to presence or absence of the designated organism based on their growth and reaction on the diagnostic media. In the harmonized test, only one medium is selected and specified organisms are narrowly defined in terms of reaction on a single medium. Presumptive isolations are required to be identified using methods not cited in USP <62>.

Table 1 shows how the two bench level stages are joined and how they differ in the pre- and harmonized MLT. Note the reduction in the number of isolations from 10 to four in the two methods. Both compendial and literature references cite the use of multiple cultures as shown in column A and the diminished sensitivity that occurs for detection of Salmonella with fewer cultures, as seen in column C^{6, 7}.

In table 2, the pre-harmonized MLT included portions of the above 20 reactions for identifications of a monograph isolate.  Our purpose in showing the information-rich review in section A and empty section B is to emphasize the value of a stand-alone document to one that requires searching for additional resource material.

Focus on Salmonella
The pre-harmonized methods in one form or another appeared in FDA BAM, AOAC and WHO references for over fifty years. In Table 1 we note that harmonization allows reduction of the original USP isolations from three to only one. For example, in the case of Salmonellae XLD was retained and Bismuth Sulfite and Brilliant Green agars were eliminated. Validation to demonstrate that one medium was as good as three was not performed by the three pharmacopeiae.

There are at least three reasons why more than one medium was recommended for many years for screening forSalmonella.  First, hydrogen sulfide, a key metabolic determinant to separate Salmonella from Shigella, admittedly, is not always produced or visible in the culture media. Second, size, color and contour of the suspect colony is variable and very subjective. Third, atypical strains (as reported by the FDA and described in AOAC) will not always be recognized if only XLD is used. Therefore, according to AOAC the presence of an atypical strain of Salmonella sp. on XLD will be incorrectly identified in USP < 62> as absent. AOAC (Salmonella in Processed Foods) cautions only against XLD as follows, “. . . atypically a few XLD Salmonella cultures produce yellow colonies with or without black centers.” It also recommends without reservation the use of Hektoen Enteric Agar or Bismuth Sulfite Agar.

An inanimate surface or material can be permissive or hostile to a microorganism depending on its water activity (Aw). Most drugs are in this category. However, USP 36 still includes articles of plant or animal origin, as encountered by Kallings years ago (Table 3). All have a history of Salmonella contamination.

We stress that the pharmaceutical industry, like the food industry, must remain ever vigilant as to employing the most sensitive techniques for isolating and identifying this ancient, ubiquitous and dangerous organism.

One notes in Table 3 the occurrence of two of the organisms that often appear in the USP <1111> Staphylococcus aureus and Pseudomonas aeruginosa. What does this tell us? Of all the organisms mentioned and reviewed in this article, these species may be the most adept in crossing environmental boundaries, S. aureus from people and P. aeruginosa from water. Tracking down sources of contamination remains as challenging as ever.

Theory of the Selective Enrichment Test
The MLT relies on the use of selective agar (Table 1). The enrichment broth with the specified incubation conditions is finely crafted to promote viability of the designated organism and inhibition of the unwanted.  There is sometimes a situation when the designated organisms are in pure culture and the only purpose of the enrichment phase is to bring it in to detectable levels. There are four inhibitory enrichment broths in use in the various MLT (Table 4). Note: Selenite cystine and tetrathionate were used exclusively in the U.S., and partially elsewhere, for many years. They are still used in USP <2022>⁹, addressing the microbiological limits of dietary supplements.

In Table 5, the commonly employed reagents used for inhibition and their mechanisms of action are shown. When the test material harbors a complex bioburden, selective microbial enrichment is a great aid in isolating the organism in question.

The Historical Most Favored Pre-Harmonized Tests
From review of the Japanese, British and European pre-harmonized methods, we have identified below the most common confirmation tests (Stage III) chosen over the years by the four nations. The committee chose none (Table 6).

For a comprehensive review of diagnostic microbiology, mechanisms of action, and various culture media, see Prince, Lechevalier and Laskin¹⁰. For future guidance the reader is referred to any early volume of the USP, JP, AOAC, BAM/FDA. For a current, more flexible, compendial view, one might read USP <2022>⁹. The reader is advised that related papers are available that address the subject of modifying the USP Microbial Limit Test, < 61>¹¹.

The Chemistry of XLD Agar
XLD agar is recommended by USP for the detection of Salmonellae. XLD, like the other media which were eliminated in harmonization, is an example of a low-cost, proven approach that is available in developed and developing countries alike and does not depend on expensive software or technology.

XLD Agar is both a selective and differential medium. It utilizes sodium desoxycholate as the selective agent and, therefore, it is inhibitory to gram-positive microorganisms. Xylose is incorporated into the medium, since it is fermented by practically all enterics except for the Shigellae; this property enables the differentiation of Shigella species. Lysine is included to enable the Salmonellae group to be differentiated from the nonpathogens since without lysine, Salmonellae rapidly would ferment the xylose and be indistinguishable from nonpathogenic species. After the Salmonellae exhaust the supply of xylose, the lysine is attacked via the enzyme, lysine decarboxylase, with reversion to an alkaline pH which mimics the Shigellae reaction. To prevent similar reversion by lysine positive coliforms, lactose and saccharose (sucrose) were added to produce acid in excess. Differentiation of pathogenic^12,13 Salmonellae is further achieved with an H₂S indicator system, consisting of the enzyme thiosulfate reductase, sodium thiosulfate and ferric ammonium citrate for the visualization of the hydrogen sulfide produced, resulting in the formation of colonies with black centers.

Case Study: A Misleading Current USP <62> Evaluation of Salmonellae and E. coli
Regardless of theory, it is our experience that reliance on a single medium — like XLD agar — in the context of narrowly focusing in on the presence of a specified organism leads to error. In an investigation of starch, conducted by the authors, it was found that, from USP <62> when suspicious colonies were picked from XLD agar and subcultured onto MacConkeys agar, that E. coli was identified. Thus, if the step of sub-culturing from XLD agar to MacConkeys was not taken, the false conclusion reached would be that Salmonellae was present when in fact it was not. Furthermore, the false conclusion that E. coli was absent would be made, and thus the presence of E. coli would not be reported. The subjectivity that is troublesome in some phenotypic assays may be overcome by some newer genetic assays. In our laboratory, in certain cases, we supplement enrichment and classical cultivation ofSalmonellae with qPCR [see Figure 1].

Potentially Adding Objectionable Organisms
The four original USP indicator (specified in the newer terminology) organisms are important, representing three ubiquitous and highly pathogenic gram negative rods (typhoid fever, diarrhea and a germ that infects wounds and mucosal tissue) and the master Gram positive pathogen shed from the nostrils, skin, hair, throat, ears and eyes (Staphylococcus aureus). Now Bacillus cereus and Burkholderia cepacia complex are openly being discussed as possible new additional specified organisms. Equally as important as adding another organism is a means to quickly identify it in a rapid and certain way. Does the culture medium exist? Can it be picked out as mistakenly as E. coli on a MacConkey plate? This subject is thoughtfully explored by Sutton and Jimenez¹⁴. The term “objectionable organism” — as distinguished from “indicated organism” in the sense of our present discussion — is derived from the GMP regulations⁵ and has legal standing. They are very common and seen with greater frequency in 483 citations than the indicated organisms associated with a microbial limit test.

Summary
The Microbial Limit Test was published by the USP in 1970 derived in part on AOAC methodology. It is based on the premise that certain indicator pathogens can serve as a screen for the infectivity of the chemical or biological material described in a monograph or elsewhere. The method is a three-stage process of eluting potential bioburden in standardized manner in a process called enrichment (Stage I), transferring any growth to special selective subculture plates designed to presumptively suggest either the absence or possible presence of the pathogen (Stage II). Thereafter simple diagnostic procedures are supplied to the analyst to identify any growth observed in Stage II so as to rule out or confirm presence of the indicator organism (Stage III). This methodology existed in a non-harmonized manner for 38 years under the purview of the USP, JP, BP and EP with certain variation.
In 2009 the test method was harmonized with what the authors consider useful and non-useful changes. Stage I was improved by the addition of superior growth media and method suitability. An even greater and major change was to limit discovery to report absence — but not presence — of an objectionable organism. The presumptive stage for the examination of Salmonella was reduced (Stage II) from the standard of as many as three cultures (USP, JP, EP, BP, AOAC, ISO, BAM, WHO) to a single culture, a non-validated reduction, without showing equivalence. The test portion in certain cases was reduced from the 10 grams to 1 gram, a 90% reduction, again, without showing the two portions to be equivalent. The authors attempt to show the emerging value of genotypic testing (such as the PCR reaction) as an adjunct to standard biochemical phenotypic testing. 

Web Source:

Microbiological Testing & Contamination Control - Contract Pharma

Indústria cosmética no Brasil: panorama e perspectivas para 2014

Confira um painel com os principais números do setor, o crescimento da  indústria em cada região nos últimos anos, os movimentos de mercado e as expectativas  dos profissionais em relação ao ano que se inicia.

Fatores como a desaceleração da atividade industrial, a inflação resistente, a menor oferta  de crédito e juros em elevação compõem um cenário de modestas estimativas de crescimento  econômico para 2014. Se para alguns setores 2013 foi embora sem deixar saudade, é  consenso em diversos segmentos que 2014 – que traz consigo a imprevisível combinação de Copa do Mundo e eleições – começou sob o signo da cautela. O otimismo, contudo,  continua presente entre os profissionais da área cosmética, ancorado no esforço inovador e  competitivo de um setor que já representa 1,8% do Produto Interno Bruto (PIB) nacional

Veja no link abaixo o restante da matéria...

| Cosmetics Online Brasil

Novas drogas mexem com mercado de hepatite C

Jornal Valor Econômico
06 de Março de 2014

Novas drogas mexem com mercado de hepatite C

A farmacêutica americana Gilead chegou quieta no Brasil e instalou seu primeiro escritório na nobre zona sul da cidade de São Paulo. Enquanto os recém-chegados funcionários ainda estão abrindo as caixas da mudança, o mercado está de olho aberto. Não somente porque a empresa é um dos grandes nomes da biotecnologia atual - com faturamento de US$ 11 bilhões e um dos maiores conjuntos de produtos em desenvolvimento do setor -, mas porque sua chegada ao país é parte de um movimento maior.

Globalmente, a indústria está experimentando o início de um processo de alteração da dinâmica do segmento de hepatite C. Os novos medicamentos prometem revolucionar os tratamentos.

A Gilead está nas manchetes da mídia internacional desde o fim do ano passado, quando foi aprovado pelo Food and Drug Administration (o FDA, o órgão regulador americano) seu novo tratamento para hepatite C, chamado Sovaldi. O medicamento foi considerado pela revista "Forbes" o mais importante lançamento do setor em 2013 e analistas preveem vendas que superarão os US$ 5 bilhões já no primeiro ano. Estas perspectivas já fizeram com que as ações da empresa na Nasdaq avançassem cerca de 20% desde dezembro até o último dia de fevereiro.

A grande novidade dessa nova classe de medicamentos é seu alto nível de eficácia. Estudos mostram que 96% dos pacientes que completaram o tratamento atingiram uma resposta sustentável, o que significa no jargão médico que o paciente ficou livre do vírus, ficando curado da doença. Além disso, com a nova tecnologia, o tratamento completo dura até 12 semanas, e não as mais de 40 exigidas pelas drogas atuais. Sendo em pílulas, e não em injeção, o medicamento promete ainda aumentar o bem-estar dos pacientes e ter menos efeitos colaterais.

Hoje, calcula-se que cerca de 170 milhões de pessoas estão infectadas com hepatite C no munto. O mercado é grande e tem atraído outras gigantes farmacêuticas, que há anos estão investindo no segmento. Muitas também alcançaram resultados satisfatórios, que devem competir com o Sovaldi.

A AbbVie pretende submeter uma nova droga à aprovação do FDA neste semestre. Ainda sem nome, o medicamento deve ser lançado em 2015 e será o primeiro do segmento no portfólio da companhia. No mesmo caminho, a Bristol-Myers Squibb vai submeter até o fim do ano o daclastavir, também será a primeira inovação da empresa na área de hepatite C.

Sendo aprovado pelos órgãos reguladores internacionais, logo os medicamentos são submetidos também à aprovação na Anvisa, a Agência Nacional de Vigilância Sanitária. Isso significa que não demorará muito para o mercado brasileiro começar a receber estes novos tratamentos.

Estima-se que hoje estão infectadas pelo vírus da hepatite C entre 2 e 3 milhões de pessoas no país. A doença é tratada pelo Sistema Único de Sáude (SUS), mas apenas cerca de 10 mil pacientes por ano recebem o tratamento. Esta diferença, em grande parte, é explicada pela falta de consciência sobre a doença. E significa também uma grande oportunidade.

"Nossa expectativa é de que este número de pacientes tratados cresça exponencialmente. O governo está investindo mais e tem dado sinais de que está preocupado (com a doença)", disse José Antonio Vieira, presidente da AbbVie no Brasil. "A área está recebendo muitos investimentos, porque é considerada uma necessidade ainda não atendida. Até agora não tinha nada que resolvesse em definitivo o problema doença", afirmou Roger Miyake, diretor de estratégia da Bristol-Myers Squibb.

Um estudo publicado no ScienceDirect - site que reúne publicações científicas - mostra que os gastos do governo brasileiro com o tratamento de hepatite C chegam a quase US$ 100 milhões por ano. Hoje, entre os mais avançados está um tratamento triplo - que combina a droga interferon peguilato, a ribavirina e um inibidor de protease. O problema é que ele ainda é árduo, tem efeitos colaterais fortes e inclui a necessidade de injeções regulares no hospital. Quando há o melhor dos resultados, 65% dos pacientes ficam livres do vírus.

Hoje, o governo tem contratos principalmente com a Roche e a MSD. A Roche, fornece para o SUS o Pegasys - com vendas globais de mais de US$ 1,5 bilhão. A MSD, por sua vez, fornece o Pegintron - que vendeu US$ 500 milhões em 2013. No fim do ano passado, o telaprevir da Janssen (braço farmacêutico da J&J) passou a ser disponibilizado pelo SUS. Segundo a empresa, com o esquema triplo, as taxas de cura chegam a 80% e o tempo de tratamento é de 24 semanas.

Com as novas terapias que estão surgindo os tratamentos tradicionais podem ser ameaçados. "A tendência é que o Brasil tenha novos players (participantes do mercado)", afirmou Eliane Kihara, consultora da PWC.

"Obviamente isso nos preocupa. Mas, estamos preparados para enfrentar a concorrência", afirmou Guilherme Leser, diretor de relações governamentais da MSD. A empresa também está desenvolvendo uma droga na mesma linha das inovações de suas concorrentes globais, que deve chegar ao mercado em quatro anos.

O único fator que pode atrapalhar os planos das estreantes no mercado de hepatite C parece ser o preço. O custo do tratamento completo da Gilead, por exemplo, é de US$ 84 mil. Segundo Eliane, existe uma preocupação de que os preços limitem a introdução dos novos tratamentos nos sistemas públicos de saúde. "As empresas terão que mostrar que vale a pena", afirmou a especialista.

O fato é que a Gilead está aproveitando este momento de inovações no exterior para se lançar no Brasil, um novo território, e intensifica a corrida na área de virologia. A empresa não quis dar entrevista.

Vanessa Dezem

fonte: http://www.abiquifi.org.br/noticias/clipping/clipping2014/06_03_14_Hepatite.html

GMP News: FDA: More Inspections in India

GMP News: FDA: More Inspections in India

In her monthly blog, FDA Commissioner Margaret A. Hamburg gives a personal overview about her recent visit in India. The Federation of Indian Chambers of Commerce and Industries organised roundtable meetings where challenges of Indian pharmaceutical and food exporting companies were discussed. More and more generics are produced in India and quite a few abbreviated new drug applications (ANDA) in the U.S. are still waiting for approval. Margaret A. Hamburg said that FDA is working on reducing the current backlog of generic drug applications. The Generic Drug User Fee Act (GDUFA) supports these actions but does also require and fund more foreign inspections. Companies participating in the roundtable meetings said "they were challenged by our heightened inspectional activities" but Hamburg emphasised that "every company supplying the U.S. market has the responsibility of ensuring that their products are safe, effective and of high-quality".

"In recent years the FDA has identified significant lapses in quality by some companies operating in the U.S. and around the world.", Hamburg said. "This is unacceptable. Consumers should be confident that the products they are using are safe and high quality and when companies sacrifice quality, putting consumers at risk, they must be held accountable.