Apologies to my readers the site has gone quite in January, I have been on Paternity leave so unable to update the site, I have started recruiting an assistant to keep on-top of things but as yet not had much luck. Normal service resumes in February.
Best Regards
Damien
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NICE has replaced previous guidance on on the closure of anal fistulas with bioprosthetic plugs with this new document. The use of the technique raises no major safety concerns however evidence efficacy is inadequate in terms of quality and quantity. Therefore it is the opinion of NICE that the procedure should only be used with special arrangements for clinical governance, consent and audit or research.
Full guidance is given below
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Tagged anal fistula, bioprosthetic plug, NICE
NICE developed guidance on the long-term management of self harm, which follows on from their earlier article the short-term physical and psychological management and secondary prevention of self harm in primary and secondary care (NICE, 2004).
These guideline recommendations have been developed by a multidisciplinary team of health care professionals, people who self harm, their carers and guideline methodologies to careful consideration of the best available evidence. It is intended that the guidance will be useful to clinicians and service Commissioners in providing planning health care for people who self harm.
a full copy of this guidance is available from the website
The FDA has developed this draft document to provide guidance to manufacturers when they would like to submit a 510 K premarket submission for changes modifications made to the previously cleared medical device. This is following an FDA review of its processes for premarket review of medical devices which highlighted industry issues and concerns in this area.
Ticagrelor in combination with low-dose aspirin has been used to treat patients with adult coronary syndrome. That is patients with ST segment of elevation myocardial infarction (STEMI), with non-ST elevation myocardial infarction (NSTEMI) or or been admitted to hospital with unstable angina. NICE has considered these indications and approved treatment Ticagrelor as it represents value for money when taken in combination with low-dose aspirin up to 12 months.
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Tagged acute coroarny syndrome, NICE, ticagrelor
The EMA has published a concept paper inviting input from industry into a proposed update to the guidance on the evaluation medicinal products indicated for treat bacterial infections, to address indication specific clinical data requirements.
this initiative follows several requests were made to the CH MP to provide more detailed guidance on issues such as Pearson selection criteria and primary endpoints including efficacy variables and the timing of assessment outcomes. Specific interest was laid out non-inferiority study designs that would be acceptable to the regulators. A number of enquiries were concerned about the feasibility of achieving superiority endpoints in clinical studies and more guidance was needed to assist companies developing clinical programs that would be feasible and meet with regulatory approval in this area.
In response to this the EMA held a number of workshops and are now looking to make changes to the guidance to meet these issues.
Posted in clinical, Uncategorized
Tagged data requirements, guidance, Treatment of bacterial infections
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This new EMA guidance document provides general principles on the setting and justification of a uniform set of specifications herbal substances and preparations. Since a simplified registration procedure was established for traditional herbal medicinal products for human use the quality medicinal products is independent of its traditional use. More specifically the addition of vitamins to herbal products need to comply with all the relevant legislation guidance.
This document is concerned with the specific definitions as a list of tests, references to analytical and biological procedures and appropriate acceptance criteria a number of limit ranges and other criteria have been as described and established.
full text here
This guidance document provides general principles on the setting and justification, to the extent possible, of a uniform set of specifications for herbal substances/preparations and herbal medicinal products to support applications for marketing authorisation or registration according to Directives 2001/82/EC and 2001/83/EC as amended. It should be read in conjunction with the ‘Guideline on quality of herbal medicinal products’ (EMA/CPMP/QWP/2819/00, EMA/CVMP/814/00, EMA/HMPC/201116/2005, as revised).
A simplified registration procedure was established for traditional herbal medicinal products for human use under Directive 2004/24/EC. The quality of a medicinal product is independent of its traditional use; therefore all general principles of quality also apply to traditional herbal medicinal products for human use. Traditional herbal medicinal products for human use may additionally contain vitamins or minerals. Concerning these products, this guideline describes specific aspects linked to mixtures of herbal substances/herbal preparations with vitamins and/or minerals. In addition, the quality, specifications and documentation for each vitamin and mineral have to comply with all relevant legislation and guidelines.
A specification is defined as a list of tests, references to analytical and biological procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a herbal substance/preparation or herbal medicinal product should conform to be considered acceptable for its intended use. “Conformance to specifications” means that the herbal substance/preparation or herbal medicinal product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are legally binding quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities.
Specifications are one part of a total control strategy for the herbal substance/preparation and herbal medicinal product designed to ensure product quality and consistency. Other parts of this strategy include thorough product characterisation during development, upon which specifications are based, adherence to the ‘Guideline on Good Agricultural and Collection Practice (GACP)’ (EMEA/HMPC/246816/2005) and Good Manufacturing Practice (GMP), and a validated manufacturing process, e.g., raw material testing, in-process testing, stability testing, etc.
In the case of herbal medicinal products, specifications are generally applied to the herbal substance, to the herbal preparation and to the herbal medicinal product. Specifications are primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterisation, and should focus on those characteristics found to be useful in ensuring the safety and efficacy of the herbal substance/preparation and herbal medicinal product.
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This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for plasma-derived fibrin sealant / haemostatic products.
The purpose of this core SmPC is to provide applicants and regulators with harmonised guidance on the information to be included in the Summary of product characteristics (SmPC) for plasma-derived fibrin sealant / haemostatic products.
The QRD product information template with explanatory notes (′QRD annotated template’)1 and the convention to be followed for QRD templates2 provide general guidance on format and text and should be read in conjunction with the core SmPC and the Guideline on summary of product characteristics3. It is very useful to provide information for health professionals on posology and method of administration at the end of the package leaflet since the SmPC is not always readily available. See the QRD annotated template for further guidance on how to present such information.
In addition, for the content of sections 4.4 and 4.8 concerning transmissible agents, refer to the current version of the Note for guidance on the warning on transmissible agents in SmPCs and package leaflets for plasma-derived medicinal products (CPMP/BPWG/BWP/561/03)4.
Timeline history of core SmPC: The original core SmPC (CPMP/BPWP/153/00) came into operation in January 2005. This revision concerns new statements in 4.4 and 6.6 for products recommended for use with gas pressurised fibrin sprayers.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
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Tagged anti-fibrinolytics, aprotinin, cerebro-spinal fluid, dura mater, factor XIII, Fibrin sealant, gastrointestinal anastomoses, glueing, haemostatics, Human Fibrinogen, human thrombin, neurosurgery, ophthalmic and vertebral surgery, otologic, rhinologic, sealant, tranexamic acid, treatment of bleeding, vascular surgery
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Pain is the most common symptom for which patients seek medical attention. Although there is no exact definition it has been defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage (International Association for the Study of Pain (IASP). Due to the subjective component of pain and the problems associated with a correct diagnosis patients are frequently undertreated for acute and chronic situations.
Nociceptive and neuropathic pain has been internationally defined. Nociceptive pain can be defined as the process by which intense thermal, mechanical, or chemical stimuli are detected by a subpopulation of peripheral nerve fibers, called nociceptors whereas neuropathic pain can be defined as pain arising as a direct consequence of a lesion or disease affecting the somatosensory system. In addition, pain can be of mixed origin (e.g. cancer pain), thus justifying that the 2 current guidelines are merged in a unique document. When current guidelines on nociceptive and neuropathic pain were written, the experience on clinical development was not large.
The different types of pain which may have different pathophysiological mechanisms and pathways should be considered in the clinical development of new analgesic agents, and the proposed models to evaluate treatment efficacy should be updated in line of the experience gained during the past years.
Fibromyalgia is a complex disease with clinical features other than pain and should be dealt with in a separate document.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
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Organisations and/or individuals that commented on the draft Community herbal monograph on Viola tricolor L. and/or subspecies Viola arvensis Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore as released for public consultation on 11 March 2010 until 15 August 2010.
Organisations and/or individuals
1 European Scientific Cooperative on Phytotherapy (ESCOP)
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
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Health Canada is in the process of creating a Medical Devices Inspection Cycle. Our goal is to make this inspection cycle risk-based. This document provides potential options in inspecting scheduling and cycles.
We are exploring changes and we would appreciate your input on key concepts that we are considering. Specially, we welcome input on (i) how we assess the risk of an establishment; (ii) appropriate inspection cycles for different levels of risk.
The following suggestions may help you prepare your comments:
Please submit your comments by November 16, 2011.
In order to provide your comments you must submit them by sending the Word or PDF format and email them to the mdcu-ucim@hc-sc.gc.ca.
Please note that any information collected will only be used for input to this consultation. The information collected will be used to create a summary report and will guide recommendations made as part of this review. The summary report will be made available to stakeholders once consultations are complete.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
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The regulations implementing the Orphan Drug Act are codified in 21 CFR Part 316. FDA published the Proposed Rule for these regulations on January 29, 1991 (56 FR 3338) (Ref. 1) and the Final Rule on December 29, 1992 (57 FR 62076) (Ref. 2). One of the incentives for orphan drug development is the exclusive approval of a product for a period of seven years. During this seven year period, no approval will be given to a subsequent sponsor’s marketing application for the same drug product for the same indication unless the subsequent product is shown by the sponsor to be clinically superior, as defined in 21 CFR 316.3 (b)(3). In determining whether or not two products would be considered the same, FDA recognized that different criteria were necessary for macromolecules versus small molecules [21 CFR 316.3(b)(13)]. Macromolecules include a variety of structures including proteins, nucleic acids, carbohydrates and closely related, complex, partly definable drugs such as vaccines or surfactants. The current definition of sameness for protein drugs [21 CFR 316.3(b)(13)(ii)(A)] however, does not adequately consider the unique nature of antibodies. The purpose of the present document is to describe FDA’s current thinking on the criteria by which two monoclonal antibody products would be considered the same under the Orphan Drug Act and its implementing regulations.
21 CFR Part 316.3(b)(13)(ii) defines sameness for a macromolecule as “…a drug that contains the same principal molecular structural features (but not necessarily all of the same structural features) and is intended for the same use as a previously approved drug…” Two protein drugs would be considered the same “…if the only differences in structure between them were due to post-translational events or infidelity of translation or transcription or were minor differences in amino acid sequence …” [21 CFR Part 316.3(b)(13)(ii)(A)]. For monoclonal antibody products, these definitions lay the groundwork for the determination of sameness but, because of the unique series of processes involved in creating an antibody molecule, additional guidance as to what would be considered the same under the Orphan Drug regulations is needed.
An antibody molecule is composed of four polypeptide chains, two identical heavy (H) chains and two identical light (L) chains. Both heavy and light chains are divided into variable (V) and constant (C) regions. The VH-VL pairs confer specificity for antigen while the constant region of the heavy chain is responsible for effector functions such as, but not limited to, complement fixation and antibody dependent cellular cytotoxicity. The variable and constant regions were so named because amino acid sequence data showed that the amino terminal regions of heavy and light chains from different antibodies had different sequences while the carboxy terminal region amino acid sequences were the same within a given isotype (class or subclass). Subsequent analysis of variable region amino acid sequences defined three hypervariable regions (also known as complementarity determining regions or CDRs) each in the VH and VL regions which form the antigen binding site of the molecule (Ref. 3). Antibody diversity is created by the use of multiple germline genes encoding variable regions and a variety of somatic events. The somatic events include recombination of variable gene segments with diversity (D) and joining (J) gene segments to make a complete VH region and the recombination of variable and joining gene segments to make a complete VL region. The recombination process itself is imprecise, resulting in the loss or addition of amino acids at the V(D)J junctions. These mechanisms of diversity occur in the developing B cell prior to antigen exposure. After antigenic stimulation, the expressed antibody genes in B cells undergo somatic mutation. Based on the estimated number of germline gene segments, the random recombination of these segments, and random VH-VL pairing, up to 1.6 x 107 different antibodies could be produced (Ref. 4). When other processes which contribute to antibody diversity (such as somatic mutation) are taken into account, it is thought that upwards of 1 x 1010 different antibodies could be generated (Ref. 5). Because of the many processes involved in generating antibody diversity, it is unlikely that independently derived monoclonal antibodies with the same antigen specificity will have identical amino acid sequences.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Article by Mark Gibson
Up until recently, reviewing translations was not accorded much, or any, importance. This is the sole reason why we often receive manuals translated into English for goods produced in East Asia that are nonsensical and useless. The reason for this is primarily cost.
Where reviews were undertaken, the back-translation method was widely practiced. While there are advantages to the back-translation approach, the disadvantages are evident: it is time-consuming and the costs of the back-translation equal those of the forward translation. However, there are areas of the pharmaceutical industry where back-translation is a Standard Operating Procedure, such as linguistic validation of measurement instruments, such as Quality of Life or Patient-Reported Outcome tools.
Nowadays, some kind of review is an industry expectation. However, because translations usually involve a rapid turn-around to the client, it has become standard practice amongst translation companies worldwide to involve an independent translator in the review process. This is primarily a proofreading exercise for spelling, grammar, syntax, etc.
Contemporary international experts in translation theory and practice now recommend a third party, or even a community review. Typically, if the translated document was intended for a healthcare professional audience, then the third party reviewer would be an expert in that field, native in the target language. If the translated document was intended for a lay audience, such as a Patient Information Leaflet, then the third party review would be one or two lay native speaker of the target language.
The review procedures differ as follows:
· Back-translation: For specific activities where this is an expectation (e.g. PRO tools)· Internal review: proofreading step for spelling, grammar, syntax, etc.
· Community review: review step for general sense, understandability, readability, cultural appropriateness.
The community review could be developed as a mini-readability test, whereby the reviewer, whether a healthcare professional or lay native speaker, could be asked to find an explain items of information in the translated document. Alternatively, the community review could entail open-ended questions for discussion about problematic sections (in an understandability context) of the document.
Some companies might value the review processes and be content to pay for quality, while others may be reluctant to fund the community review in particular, perhaps viewing it as excessive. The solution to these objections is simply to educate about the importance of the review processes, but, above all, listen to the client and supply their needs.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
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The attached Drug Submission Application form is designed to assist manufacturers and sponsors in submitting information required to initiate the evaluation of any one of the following types of submissions:
The attached Guidance Document provides instructions on each field of the form. Please read it in its entirety prior to completing the form.
For Drug Identification Number applications, a separate completed HC/SC 3011 must be provided for each formulation, strength and dosage form. For all other submission types, only a separate completed Part 2 must be provided for each formulation, strength and dosage form.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
BBC Health News