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The MHRA’s goal is to reduce the burden is the users and simplify the law.

Joint inspections on good clinical practice were undertaken in a large number of clinical programs, as well as joint inspections of active pharmaceutical ingredients manufacturing plants.

All agencies have agreed that the programs have been a success and will continue on this collaborative approach in future. This is clearly start of international recognition between the agencies inspection standards, which should have positive effects of mutual recognition and reduce the regulatory burden of companies operating internationally in our industry.

Excerpt  from announcement

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Two pilot programmes of collaboration on inspections between the European Medicines Agency (EMA) and its international partners in the United States and Australia have concluded successfully, according to two reports published today. The two programmes focus on increasing international regulatory collaboration among the regulatory agencies so that drug quality and safety can be enhanced globally.

The report on the joint good clinical practice (GCP) inspection pilot programme details the success of information-sharing and collaboration on inspections relating to clinical trials. Under the joint GCP inspection pilot, the EMA and the US Food and Drug Administration (FDA) exchanged more than 250 documents relating to 54 different medicines and, in conjunction with the GCP inspectors of the EU Member States, organised 13 collaborative inspections of clinical trials. This lays the foundation for a more efficient use of limited resources, improved inspectional coverage and better understanding of each agency’s inspection procedures. It demonstrates how the agencies can work together to improve the protection of participants in clinical trials and better ensure the integrity of data submitted as the basis for drug approvals.

The report on the joint active pharmaceutical ingredients (API) inspections pilot programme details the success of information-sharing and collaboration on API inspections among the participating authorities (EMA, France, Germany, Ireland, Italy, United Kingdom, EDQM, FDA and Australia’s Therapeutic Goods Administration (TGA)). Over the course of the 24-month pilot phase, the participants shared their surveillance lists and found 97 sites common to all three regions, resulting in the exchange of nearly 100 inspection reports and in nine joint inspections.

Both pilots involved the exchange of considerable amounts of information and the establishment of inspections carried out jointly by the agencies. This led to increased levels of understanding between the agencies, and a greater number of inspections of value to more than one authority.

Based on the positive experience in the two pilots, the agencies have agreed to continue with their collaboration on inspections, taking into account the experiences and lessons learned during the pilot phases.

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This Compliance Policy Guide (CPG) describes how we intend to exercise our enforcement discretion with regard to drugs marketed in the United States that do not have required FDA approval for marketing. This is a revision of a guidance of the same name that was issued in June 2006. The guidance has been revised to state that the enforcement priorities and potential exercise of enforcement discretion discussed in the guidance apply only to unapproved new drugs (including new drugs covered by the Over-the-Counter (OTC) Drug Review), except for licensed biologics and veterinary drugs, that are commercially used or sold2 prior to September 19, 2011.

For historical reasons, some drugs are available in the United States that lack required FDA approval for marketing. A brief, informal summary description of the various categories of these drugs and their regulatory status is provided in Appendix A as general background for this document. The manufacturers of these drugs have not received FDA approval to legally market their drugs, nor are the drugs being marketed in accordance with the OTC drug review. The new drug approval and OTC drug monograph processes play an essential role in ensuring that all drugs are both safe and effective for their intended uses. Manufacturers of drugs that lack required approval, including those that are not marketed in accordance with an OTC drug monograph, have not provided FDA with evidence demonstrating that their products are safe and effective, and so we have an interest in taking steps to either encourage the manufacturers of these products to obtain the required evidence and comply with the approval provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) or remove the products from the market. We want to achieve these goals without adversely affecting public health, imposing undue burdens on consumers, or unnecessarily disrupting the market.
The goals of this guidance are to (1) clarify for FDA personnel and the regulated industry how we intend to exercise our enforcement discretion regarding unapproved drugs and
(2) emphasize that illegally marketed drugs must obtain FDA approval.

For Assistance with Registration and Compliance for OTC Products Click Here

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.

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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 purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment or prevention of neglected diseases of the developing world. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall drug development program for the treatment or prevention of neglected tropical diseases (NTDs), as defined in section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including clinical trial designs and internal review standards to support approval of drugs. This draft guidance is intended to serve as a focus for continued discussions among the review divisions in the Office of Antimicrobial Products, pharmaceutical sponsors, the academic community, and the public.

This guidance addresses section 740 of the Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act, 2010 (Public Law 111-80), dated October 21, 2009, that directed the FDA to provide guidance in the form of general recommendations and regulatory considerations for drugs being developed for the treatment or prevention of NTDs.3 Section 740 references the NTDs included in section 524(a)(3) of the FD&C Act, as follows:

• Tuberculosis
• Malaria
• Blinding trachoma
• Buruli Ulcer
• Cholera
• Dengue/dengue hemorrhagic fever
• Dracunculiasis (guinea-worm disease)
• Fascioliasis
• Human African trypanosomiasis
• Leishmaniasis
• Leprosy
• Lymphatic filariasis
• Onchocerciasis
• Schistosomiasis
• Soil-transmitted helminths
• Yaws

This guidance is intended to clarify the regulatory requirements for drug approval in the United States as well as the internal review standards for drugs for these NTDs. Specifically, this guidance is directed to sponsors who lack general knowledge about drug development issues. Pharmaceutical sponsors with experience in drug development will find this guidance to be basic, but we acknowledge that sponsors interested in evaluating investigational drugs for NTDs may have little experience in working with the FDA on drug development issues, and this guidance is intended to help them better understand the FDA processes.

Potential sponsors should understand that: (1) we will review and comment on clinical development programs for NTDs under an investigational new drug application (IND) submission, regardless of where the clinical development will take place; (2) we can approve a drug for treatment of an NTD not endemic in the United States; (3) the regulatory pathways and internal review standards for approval of drugs for NTDs are the same as for approval of drugs for diseases endemic in the United States; and (4) we are committed to exercising our regulatory authorities to facilitate access to therapies that can help reduce morbidity and mortality associated with NTDs. Specifically, FDA regulations give the FDA considerable latitude “to exercise its scientific judgment to determine the kind and quality of data and information an applicant is required to provide . . . to meet the statutory standards [for approval]” (21 CFR 72 314.105(c)). FDA regulations also specifically require that we consider the severity of disease and the absence of alternative satisfactory therapy in weighing whether the benefits of therapy outweigh known and potential risks (21 CFR 312.84(a)). In addition, there may be circumstances when one trial provides adequate evidence of efficacy.

For Assistance with Developing Products in the Developing World Click Here

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.

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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 aim of this workshop is to provide regulatory assistance to sponsors developing orphan drug designation applications.

For Assistance with Orphan Drug Applications in the EU or USA Click Here

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.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

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 aim of this workshop is to provide regulatory assistance to sponsors developing orphan drug designation applications.

For Assistance with Orphan Designation in the USA or EU Click Here

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.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

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 European Medicines Agency is organising this public-awareness event to inform attendees about the electronic submission of medicinal product information in line with the provisions set out in the new pharmacovigilance legislation and the five identification of medicinal product standards under finalisation by the International Organization of Standardization. Registration open until 15/09/2011. Places limited.

For Assistance with Ongoing Regulatory Compliance Click Here

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.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

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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As of April 1, 2011, establishment licences will no longer expire on December 31 of each year. In order to continue to hold a valid establishment licence, an application for annual review along with the appropriate payment must be submitted to Health Canada before April 1 of each year. Please find below the links to the updated information including letters, application forms and other relevant documents that must be used for preparing your annual review application.

For Assistance with Health Canada Filings Click Here

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.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

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 Food and Drug Regulations, more specifically sections C.01.016 to C.01.020, and C.08.007 and C.08.008,set forth regulatory requirements for manufacturers, which includes Marketed Authorisation Holders (MAH) and importers, regarding the reporting of adverse drug reactions and the reporting of unusual failures in efficacy of new drugs to Health Canada. As part of Health Canada’s mandate to maximize the safety, quality and efficacy of health products, Health Canada implemented on August 1, 2004, an inspection programme for PMRC. The PMRC inspection program is intended to verify that manufacturers are in compliance with the regulatory requirements including but not limited to, the receipt, analysis and submission of drug safety information to Health Canada, such as the reporting of domestic and foreign adverse drug reactions within 15 days, the preparation of annual summary reports, the maintenance of records related to reports, case reports and unusual failures in efficacy, as well as the reporting of domestic cases of unusual failures in efficacy for new drugs within 15 days.

For Assistance with Global Regulaotry Compliance Click Here

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.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

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.”