Drug Development Consultant & Regulatory Consultant » marketing

FDA Publish E2C Clinical Safety Data Management Guidance

damienbove — Mon, 12 Dec 2011 08:26:28 +0000

In order to bring FDA processes in line with ICH guidance and to harmonise technical requirements for registration of marketing approval, the FDA has published this updated guidance on the frequency of submissions and for the content of periodic safety updates. The goal is to bring all three regions (EU, Japan, United States) into harmonisation.

NICE Publish Guidance on EOS 2D/3D Imaging Systems

admin — Sat, 03 Dec 2011 10:37:57 +0000

The EOS 2D/3D imaging system is an emerging technology with potentially important clinical benefits. Current evidence shows there are some patient benefits for people with spinal deformities in terms of radiation dose reduction and increased throughput. However, those
benefits alone are insufficient to justify the cost of the system. No clinical evidence was available to quantify the extent of patient benefits from the EOS system’s imaging features including 3D reconstruction, weight-bearing whole-body imaging, and simultaneous posteroanterior (PA) and lateral imaging. Therefore, the EOS 2D/3D imaging system is not currently recommended for routine use in the NHS.

NICE encourages use of the EOS 2D/3D imaging system in specialist research settings to
collect evidence about potentially important clinical benefits associated with 3D reconstruction,
single image weight-bearing whole-body imaging and simultaneous PA and lateral imaging.

EMA starts review of Orilistat containing medicines

damienbove — Fri, 11 Nov 2011 08:27:24 +0000

The European medicines agency (EMA) has started a review Orilistat containing anti-obesity medicines, there is a concern that rare cases of hepatic injury had impacted on the benefit risk profile of these drugs.

The review will focus on is Xencical well as a number of medicines that are either regulated centrally or nationally. The risk of liver reactions with these drugs has been well-known and kept under tight review.

excerpt from release

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The European Medicines Agency has started a review of orlistat-containing anti-obesity medicines, to determine whether the very rare cases of hepatic injury have an impact on their benefit-risk profile and conditions of use.

The review includes the centrally authorised prescription-only medicine Xenical (orlistat 120 mg) and the centrally authorised over-the-counter-medicine Alli (orlistat 60 mg), as well as a number of medicines containing orlistat that have either already or are in the process of being authorised at national level.

The risk of liver reactions with orlistat is well known and had been kept under close review by the Agency’s Committee for Medicinal Products for Human Use (CHMP) since the initial marketing authorisation of these medicines. The risks of liver reactions is reflected in the product information for centrally authorised orlistat-containing medicines and addressed in the risk management plan. The CHMP is currently harmonising the product information for both centrally authorised medicines. The vast majority of reports of liver injury are not serious, and severe liver injury has been reported only very rarely. The new review focuses on the strength of evidence relating to severe liver injury.

The most recently submitted analysis, which covers of cases of hepatic events reported with orlistat 120 mg between 8 August 2009 and 31 January 2011, identified a total of 21 suspected cases of which 4 were cases of severe liver toxicity (one fatal case of hepatic failure, one case of hepatic failure leading to liver transplantation, one case of exacerbation of hepatitis and one case of hepatitis). Overall, between 1997 until January 2011 there were 21 cases of suspected serious liver toxicity for which a causal link to orlistat cannot be excluded, although these cases do not provide strong evidence of a link to orlistat as alternative explanations for liver injury are present in many of the cases. Furthermore, the number of cases needs to be considered in the context of cumulative usage of these medicines in 38 million patients.

During the period between May 2007 and January 2011 there were a total of 9 reports of suspected severe liver injury with orlistat 60 mg, although in some cases other possible explanations for liver injury were present and some cases provided insufficient information to allow assessment. These 9 cases need to be considered in the context of cumulative usage in 11 million patients.

The Committee is now reviewing all relevant data on the risk of hepatotoxicity of orlistat-containing medicines and will issue an opinion on whether or not the marketing authorisations for these medicines should be revoked, suspended or changed.

EMA release concept paper on Pharmacovigilance and implementation

damienbove — Thu, 10 Nov 2011 08:23:51 +0000

The European commission is seeking views from the public and industry on a concept paper dealing with the implementation of measures for performance activities related to safety monitoring of medicines. The paper is open for consultation until 7 November and provide technical details of the European medicines agency (EMA) marketing authorisation holders need to apply to their businesses.

excerpt from release

Full Text Here

The European Commission is seeking views from the public on a concept paper on implementing measures for the performance of activities related to the safety monitoring of medicines.

The paper, which is open for consultation until 7 November 2011, provides technical details that the European Medicines Agency, medicines regulatory authorities in European Union (EU) Member States and marketing-authorisation holders will need to apply when implementing the new pharmacovigilance legislation.

The document provides details on:

pharmacovigilance system master files;
the quality system for the performance of pharmacovigilance activities;
the use of internationally agreed terminology, formats and standards;
monitoring data in the EudraVigilance database;
the electronic transmission of suspected adverse reactions;
electronic periodic safety update reports and risk-management plans;
post-authorisation safety studies.

The Agency and representatives from Member States provided technical expertise to help with the preparation of this document.

The concept paper is available to download from the European Commission’s pages on pharmacovigilance. All comments on the paper should be sent directly to the Commission.

This consultation process is a key step in the implementation of the pharmacovigilance legislation. The Agency is working closely with the European Commission, as well as national medicines regulatory authorities, patients, healthcare professionals and pharmaceutical companies, to ensure the effective implementation of the new legislation.

The launch of this consultation is in line with the target in the implementation plan for the new legislation.

MHRA Publishes Updated Advertising of Medicines Guidance

admin — Wed, 26 Oct 2011 12:10:23 +0000

MHRA Publishes Updated Advertising of Medicines Guidance

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This guidance has been developed by the Medicines and Healthcare products Regulatory Agency (MHRA) and is supplementary to the regulatory framework as set out in the Medicines (Advertising) Regulations 1994 (“the Advertising Regulations”, SI 1994/1932 as amended) which implement Titles VIII and VIIIa of European Directive 2001/83/EC. General advice on compliance with the Advertising Regulations is given in the MHRA Blue Guide.
The internet is used widely to provide information to consumers and to promote products and services. This guidance is intended primarily for companies and organisations which do not hold marketing authorisations for medicines but which provide services that may lead to the prescription and supply of a prescription only medicine (POM). The guidance seeks to ensure that the content of such websites does not contravene the Advertising Regulations. In particular, it highlights the prohibition by regulation 7 of the Advertising Regulations of advertisements to the public likely to lead to the use of a POM. It is designed to help advertisers to promote their services without promoting specific POM medicines and thereby coming within the scope of the Advertising Regulations.
If a complaint is received, the decision on whether a particular website complies with the Advertising Regulations will be taken by the MHRA on a case by case basis, having regard to the circumstances of the particular case.

For Assistance with Regulatory Compliance with Marketing and Adverting Campaigns 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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FDA Publish Guidance on Time and Extent Applications for NonPrescription Drug Products

admin — Sun, 23 Oct 2011 12:02:03 +0000

FDA Publish Guidance on Time and Extent Applications for Non Prescription Drug Products

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This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-thecounter (OTC) drug monograph system and to describe the process for submitting that information. FDA regulations set forth criteria and procedures by which OTC drugs that initially were marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any U.S. marketing experience can be considered for inclusion in the OTC drug monograph system (21 CFR 330.14). The regulations establish a two-part process. First, to determine whether a drug product is eligible to be considered for inclusion in the OTC drug monograph system, certain information must be submitted in a time and extent application (TEA) to show that a drug product can meet the statutory standard of marketing to a material extent and for a material time.2 Second, if the drug product is found eligible to be considered for inclusion in the OTC drug monograph system, we will publish a notice of eligibility in the Federal Register that requests that interested persons submit data to demonstrate the safety and effectiveness of the drug product for its OTC use(s) (21 CFR 330.14(e) and (f)).

This guidance describes the format and content of a TEA that is used to determine if a drug has been marketed OTC to a material extent and for a material time, and what happens after a TEA is submitted. Drug products covered by this guidance are those OTC drug products that: (1) were initially marketed in the United States after the OTC drug review began on May 11, 1972; or (2) are without any U.S. marketing experience.

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MHRA Publish Updated Guidance on Consumer Websites

admin — Mon, 17 Oct 2011 08:53:54 +0000

MHRA Publish Updated Guidance on Consumer Websites

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The internet is used widely to provide information to consumers and to promote products and services. This guidance is intended primarily for companies and organisations which do not hold marketing authorisations for medicines but which provide services that may lead to the prescription and supply of a prescription only medicine (POM). The guidance seeks to ensure that the content of such websites does not contravene the Advertising Regulations. In particular, it highlights the prohibition by regulation 7 of the Advertising Regulations of advertisements to the public likely to lead to the use of a POM. It is designed to help advertisers to promote their services without promoting specific POM medicines and thereby coming within the scope of the Advertising Regulations.
If a complaint is received, the decision on whether a particular website complies with the Advertising Regulations will be taken by the MHRA on a case by case basis, having regard to the circumstances of the particular case.

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EMA Announce Meeting on Excellence in Pharmacovigilance in Clinical Trials and Post Marketing

admin — Thu, 08 Sep 2011 11:17:55 +0000

EMA Announce Meeting on Excellence in Pharmacovigilance in Clinical Trials and Post Marketing

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This course is designed to provide a firm grounding in key aspects of global clinical pre- and post-marketing safety.

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EMA Announce Meeting on Electronic Prescribing

admin — Mon, 05 Sep 2011 15:17:44 +0000

EMA Announce Meeting on Electronic Prescribing

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This event is part of the electronic summary of product characteristics (e-SPC) project which aims to enhance patient safety, drug efficacy and improve pharmacotherapy by making the prescribing process more customised to individual patient’s needs. Registration open until 23/09/2011 by completing and returning the registration form via email.

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MHRA Publish POM to P Switch Proposal for Pariet 10mg

admin — Sat, 20 Aug 2011 09:41:02 +0000

MHRA Publish POM to P Switch Proposal for Pariet 10mg

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Rabeprazole sodium is a substituted benzimidazole gastric proton pump inhibitor (PPI) (ATC Code: A02BC04). Clinical trials have confirmed the efficacy of rabeprazole in the treatment of gastro-oesophageal reflux disease (GORD) including symptomatic relief of heartburn.

The 10mg dose of rabeprazole has been available as a prescription only medicine for Symptomatic GORD with the same posology since 2001 in the UK: Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD): 10mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10mg once daily when needed.

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