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The purpose of this document is to recommend international standards for, and promote harmonization of, the nonclinical safety studies recommended to support human clinical trials of a given scope and duration as well as marketing authorization for pharmaceuticals. Harmonization of the guidance for nonclinical safety studies will help to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.
This is a revision of the ICH guidance “M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals” that published in 1997. The revisions further harmonize recommendations in a number of areas and include a new section on exploratory clinical studies. This revised guidance discusses other nonclinical studies that should be conducted on a case-by-case basis as appropriate, including phototoxicity studies, immunotoxicity studies, juvenile animal toxicity studies, and abuse potential studies.
This guidance should facilitate the timely conduct of clinical trials, reduce the use of animals in accordance with the 3R (reduce/refine/replace) principles, and reduce the use of other drug development resources. Although not discussed in this guidance, consideration should be given to use of new in vitro alternative methods for safety evaluation. These methods, if validated and accepted by all ICH regulatory authorities, can be used to replace current standard methods. This guidance promotes safe, ethical development and availability of new pharmaceuticals.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.
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Posted in pre-clinical
Tagged FDA, ICH, ICH M3(R2), ICHM3, ICHM3(R2), Non-clinical, preclinical, requirements
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The ‘Community list of herbal substances , preparations and combinations thereof for use in traditional herbal medicinal products’ is established by the European Commission based on proposals from the Committee on Herbal Medicinal Products (HMPC), in accordance with Directive 2001/83/EC as amended. The list is being developed gradually through entries of structured information relating to individual herbal substances or preparations.
Inclusion in the Community list of a herbal substance/preparation represents a significant advantage to applicants seeking registrations for traditional herbal medicinal products. This is because once a herbal substance/preparation is included in the Community list an applicant will not be required to provide evidence of the safe and traditional use of a medicinal product for which he seeks a traditional use registration if he demonstrates that the proposed product and related claims in the application comply with the information contained in the list.
Once a herbal substance/preparation is included in the Community list, competent authorities will not have the opportunity to require additional data to assess the safety and the traditional use of the product. In view of this, the HMPC has concluded that, where data on genotoxicity are inadequate or absent, it will not be possible to endorse the herbal substance/herbal preparation for inclusion in the Community list.
As a result, progress with the development of Community list is being hampered by the absence of genotoxicity data. Experience to date confirms that many well known traditional herbal substances/preparations, already widely available within the Community, will be excluded from the Community list solely as a consequence of absence of genotoxicity data and thus any potential benefits of the list to applicants will be lost.
To assist applicants, the HMPC has developed a guideline, ‘Guideline on the assessment of genotoxicity of herbal substances/preparations’ (EMEA/HMPC/107079/2007) which describes a general framework and practical approaches on how to assess or to test the potential genotoxicity of herbal substances/preparations and how to interpret the results. The stepwise approach described in the guideline sets out a pragmatic approach to address both scientific aspects of genotoxicity testing and the special needs of herbal medicinal products within the current regulatory framework applicable to these products.
Strictly speaking, genotoxicity testing should be carried out by individual applicants on their specific materials and it is recognised that this represents a major task and considerable duplication of effort particularly for applicants seeking registrations for traditional herbal medicinal products. Industry has therefore been encouraged to consider undertaking collaborative research on genotoxicity and one such study is underway within some Member States.
Community herbal monographs established by the HMPC set out the well-established and/or traditional uses for a particular plant species. The individual monographs usually cover a range of herbal preparations depending on the therapeutic uses of the particular plant. For example, the monographs for Melilot herb and Passiflora herb include a range of preparations as shown in the tables below. This guidance offers a strategy to reduce the number of test materials such that a representative range of herbal preparations is tested rather than requiring individual manufacturers to undertake their own testing on specific preparations.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.
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Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.
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This guidance provides recommendations to pharmacies on the advance compounding of Tamilfu oral suspension to provide multiple prescriptions. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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This draft guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations. The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review. When finalized, this document will supersede the Information Sheet, Continuing Review After Study Approval (September 1998, Office of Health Affairs, Food and Drug Administration).
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The first three state of the art manufacturing research centres funded under a new £70M Government investment will be based at Southampton, Loughborough and Brunel universities, to help UK businesses develop the technology products of the future and underpin manufacturing growth, Business Secretary Lord Mandelson announced today.
The three new Engineering and Physical Sciences Research Council (EPSRC) centres will focus research efforts in the fields of:
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.
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The MHRA has received numerous reports of damaged covers and associated interior mattress contamination. Mattress covers can become damaged at any time during use or storage, for example from: needle stick; strike-through damage from sharp objects; abrasion during handling, transport or movement; inappropriate cleaning and decontamination procedures.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.
As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.
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“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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This guideline intends to address the EU regulatory position on the main topics of the clinical development of new medicinal products in the treatment of patients with gastroesphageal reflux disease (GERD).
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.
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“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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This Concept Paper proposes a revision of the Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products (CPMP/BWP/3088/99) that came into effect in 2001. The revision of the Note for Guidance, Guideline according to the new terminology, will address the issues identified from clinical experience and provision of Scientific Advice on gene therapy medicinal products and will lay down detailed and updated requirements for the quality, nonclinical and clinical aspects of gene therapy medicinal products. The revised Guideline will refer to a number of recently developed scientific guidelines and will comply with Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products and the Commission Directive 2009/120/EC amending of the Annex I Part IV of Directive 2001/83/EC
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.
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“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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This Q&A document is developed and maintained by the Agency’s CHMP Gene Therapy Working Party in collaboration with other relevant Working Parties and with the Committee for Advanced Therapies (CAT). A number of questions that have been brought to the attention of the GTWP by different stakeholders, on matters related to the development of gene therapy medicinal products, are addressed. It provides harmonized position on issues that can be subject to different interpretation or require clarification, typically arising from discussions during briefing meetings with stakeholders.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.
As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.
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“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.”
Posted in biotechnology, clinical, pre-clinical
Tagged CAT, Committee for advanced Therapies, gene therapy, GTWP
For those that visit the IDA “office” you will know we take our coffee seriously, and our favourite supplier LeCafeShop , has just given us a huge boost: – this is arguably on the best coffees in the world and we will most definitely be buying more of it.
Get yours in quick - Jamaican Blue Mountain Coffee
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This guidance is intended to encourage manufacturers of medically necessary drug products (MNPs) and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production facilities. In CDER’s Manual of Policies and Procedures (MAPP) 6003. “Drug Shortage Management,” a medically necessary drug product is defined as: Any drug product that is used to treat or prevent a serious disease or medical condition for which there is no other adequately available drug product that is judged by medical staff to be an appropriate substitute. The guidance provides considerations for the development and implementation of a contingency production plan that will ensure the highest possible quality MNP under the circumstances, including specific elements that should be included in the plan. The guidance also discusses the Center for Drug Evaluation and Research’s (CDER’s) intended approach to helping to avoid drug product shortages that could have a negative impact on the national public health during such emergencies. The guidance is intended for manufacturers of drug and therapeutic biological products regulated by CDER and manufacturers of raw materials and components used in those products. FDA encourages drug product manufacturers to show this guidance to all suppliers and contractors associated with the manufacture of MNPs and to discuss the guidance with them to stimulate planning to avoid or mitigate disruptions in supply.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.
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“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.”
Posted in business, manufacturing
Tagged contignecy, emergencies, Medically necessary drug products, MNPs, production
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FDA intends this guidance to assist developers of medical imaging devices and imaging drug/biological products (hereinafter more generally referred to as drugs or drug products) that provide image contrast enhancement in determining:
• When the imaging device developer may add certain new imaging contrast indications to its device for use with already approved imaging drugs without a need for a modification of the drug labeling;
• When the imaging drug developer may add certain new imaging contrast indications to its drug for use with already approved imaging devices without a need for a modification of the device labeling, and
• What type of marketing submission(s) the imaging drug or imaging device developer should submit to FDA to request approval/clearance to add a new imaging contrast indication.
FDA intends for the principles in this guidance to promote timely and effective premarket review of, and to promote consistent, appropriate regulation and labeling for imaging drugs and devices. These principles are intended to: 1) promote consistency in the type of scientific or technical information submitted to establish a new imaging contrast indication for use regardless of the type of marketing submission, and 2) to promote compatibility in labeling indication statements.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.
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“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 Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, are recognizing as acceptable for use by you, manufacturers of blood and blood components intended for transfusion subject to United States statutes and regulations the instruction circular entitled “Circular of Information for the Use of Human Blood and Blood Components” (Circular) dated December 2009. The December 2009 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion. We believe that the Circular will assist you in complying with labeling requirements under 21 CFR 606.122 (§ 606.122). The requirements under § 606.122 specify that an instruction circular must be available for distribution with blood and blood components intended for transfusion. Section 606.122 further specifies the information that is required in the instruction circular. This guidance supersedes the guidance of the same title dated October 2009.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.
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“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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This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
This annex is the result of the Q4B process for the Sterility Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.
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“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.”
Posted in manufacturing
Tagged EWG, ICH, PDG, Pharmacopeil Discussion Group, Q4B, Sterility
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This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
This annex is the result of the Q4B process for Disintegration Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.
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“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.”
Posted in manufacturing
Tagged disintigration, ICH, PDG, Pharmacopoeial Discussion Group, Q4B, WEG
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