Tag Archives: CTD Module 3

Some impacts of the Falsified Medicines Directive 2011/62/EU (amending Directive 2001/83/EC)

Falsified active substances and active substances that do not comply with applicable requirements of Directive 2001/83/EC pose serious risks to public health. 

In recent blog posts I have pointed out certain new developments arising because of the Falsified Medicines Directive (FMD) that affect the control of API’s.  Today I want to write about excipients!

Excipients and there are more than a thousand used in EU medicines are also subject to the new FMD legislation.  For instance the Directive states:

“There is a range of different good manufacturing practices that are suitable for being applied to the manufacturing of excipients.  In order to provide for a high level of protection of public health, the manufacturer of the medicinal product should assess the suitability of excipients on the basis of appropriate good manufacturing practices for excipients.”

This requirement will be achieved by formalised risk assessments to judge if each excipient is suitable for its intended purpose [refer to Articles 46(f) and 47 (fifth paragraph) of the FMD].

To increase your understanding of the regulatory and compliance issues affecting Substances for Pharmaceutical Use please book to reserve your place at our upcoming (2-3 July 2013) CTD Module 3 course in London.  Bookings close very soon!

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Have you seen what is coming?

Recent developments influencing the updating of our popular CTD Module 3 course include new legislation (the Falsified Medicines Directive), new guidance on impurities particularly in drug substances, the upcoming 8th Edition of the European Pharmacopoeia …. and more. 

At our course we anticipate keen interest in our ‘FMD explanations, consequences and updates’, and an informative, group interactive discussion on these subjects.  FMD impacts are many and apply from ‘where and how the drug substance is synthesised’ through numerous aspects of ‘dosage form manufacture, any import into the EU, and other facets of distribution, traceability and verification’ to ensure that the patient receives the intended pharmaceutical treatment.

In addition, other specific FMD questions to be addressed include:

Which Member States remain slow to transpose the FMD into national legislation?

Which countries are Equivalent Countries?

Which countries will issue Written Confirmations?  Will some countries have a number of State systems rather than a single national one?

Are contingency plans in place for certain ‘at risk’ situations in certain Member States?

More personally, are you someone who has already seen the ‘FMD train coming down the track’ probably from distant places, and wants to learn much more?  Or is this fresh news to you?

The evolving compliance issues are hugely important extending as they do from ‘active substance starting materials and the definition and acceptance thereof’ right up to the point of ‘dispensing of medicines in local pharmacies in our own communities’ …. and lots that goes between!

Rather a lot of new Quality subjects for pharmaceutical regulatory personnel and others to learn about, on top of the basics of Module 3 regulatory science!

Please hurry to book if you want to secure a place.

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Designating API starting materials acceptably in a chemical synthesis

Making the correct designations of ‘active substance starting materials’ in a chemical synthesis can be very difficult but is extremely important to your company.  There is a subjective element to overcome and only a limited set of rules to help you with the decisions.  These will be discussed and some examples considered in our comprehensive CTD Module 3 course in London on 2 – 3 July 2013.

The impact of the designations on GMP compliance with regard to development costs and to the time taken to gain regulatory approvals of Marketing Authorisation applications can be huge, so increasing your understanding of the many issues is more than sensible!  Please hurry to book if you want to secure a place.  Bookings close soon.

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A reminder that bookings are now open for our next PHARMACEUTICAL REGULATORY TRAINING COURSE

Title:  On the Background, Content and Detail of Module 3 of the Common Technical Document (CTD), the ‘QUALITY MODULE’ being held on 2-3 July 2013 at the Royal Society of Chemistry, Burlington House, Piccadilly, London

Do not delay too long to book your place as numbers are limited!

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VERY USEFUL, COMPETENTLY-JOINED UP, ENJOYABLE AND MOTIVATING

For any new Marketing Authorisation (MA) application, the applicant’s choice both of the legal basis and of the application submission procedure is important.  Decisions about these subjects can impact significantly on pharmaceutical and other development work, on a variety of pre-licensing submission activities, on eventual marketing opportunities and on the potential for product family enlargement.

“Full” MA applications such as are required for New Drug Products (which are those that contain a New Drug Substance) have to be supported by large amounts of relevant experimental, scientific and clinical data to support the Quality, Safety and Efficacy of the New Drug Product.

“Abridged” MA applications are less than “Full” but must also satisfy the licensing authorities with regard to Quality, Safety and Efficacy.  This can sometimes be done in different ways.

‘Generic Products’ form a particular and very important category of “Abridged” applications.

Use of generic medicines is now central to many people’s care, particularly in the UK where a growing number of people diagnosed with a long-term condition (e.g. diabetes, cardiovascular conditions, mental illness) can be treated less expensively than with innovator medicines.  The considerable savings [£9.6 billion per year just in England & Wales alone, according to British Generic Manufacturers Association (BGMA)] can be diverted towards other forms of healthcare including the use of New Drug Products.  It is also interesting to note the BGMA’s figures showing that the average cost to the UK National Health Service (NHS) of a branded medicine is £19.73 in contrast to £4.01 for the average cost of a generic medicine.

Increasingly, EU health budgets outside the UK are also benefitting from lower costs of medicines achieved through generic prescribing and dispensing.  An overall consequence is that in the EU the reduced cost of medicines (amounting to billions of pounds and billions of euros) allows more patients to be treated and also releases resources which are in turn invested in new and innovative treatments for patients.

It’s therefore not surprising for the above reasons and more that the EU considers that Generic Medicines are important enough to have special legislation facilitating their development and approval.  As a result MA applications for generic medicines benefit from a legal derogation whereby the results both of pre-clinical (non-clinical) tests and of most clinical trials “shall not be required”.  However, applicants for MAs for Generic Medicines are not excused from providing satisfactory results from relevant pharmaceutical testing.

There is a number of special requirements expected of Generic Product manufacturers that have been laid down in EU legislation and interpreted through various, indeed many, official guidance documents.  The key subjects have complexities that need to be learned, understood and satisfied by the generics industry guided by their regulatory affairs staff.  Expert training about pharmaceutical testing and about generic product specifics is available (see www.pharmaqmtraining.eu) to interested parties from distinguished speakers such as:

Derek Calam  who is a Visiting Professor of Pharmaceutical Sciences, University of Strathclyde, a Member of the WHO Expert Panels for both Pharmaceuticals and Biologicals and Chairman of the WHO Committee responsible for allocating names to medical substances on a global basis, a UK-nominated Expert at the European Medicines Agency (EMA) in London, and much more.

Formerly Head of Chemistry Division at the National Institute for Biological Standards and Control, formerly Chairman of the European Pharmacopoeia Commission and of the British Pharmacopoeia Commission, formerly Chairman and Member of the EDQM Steering Committee for Certification, Strasbourg.

David Snodin who is Principal, Xiphora Bipharma Consulting, a Fellow of the Royal Society of Chemistry, a Member of The Organisation for Professionals in Regulatory Affairs and a Registered Euro Toxicologist.  David is recognised internationally for his insight, foresight and great expertise on the control of genotoxic and other impurities in innovator and generic products.  He is an experienced international lecturer and author/co-author of many modern scientific papers on Safety Evaluation of Biopharmaceuticals and other products including generic medicines.

Working formerly in the food and pharmaceutical industries, David then joined the UK Licensing Authority (now the Medicines and Healthcare products Regulatory Agency (MHRA)] where he became an Expert Preclinical Assessor and the UK representative on the CPMP Safety Working Party.  David then worked for PAREXEL Drug Development Consulting for over 8 years where he was Vice President Nonclinical before establishing Xiphora Bipharma Consulting.

Paul Fleming who is Technical Director of the BGMA (which represents and promotes the views of the generic medicines industry in UK and has close and regular discussions with MHRA, other parts of the Department of Health and the NHS) and at a European level, a key Member of the Regulatory Committee of the European Generic Medicines Association, EGA.  In both these roles, Paul is involved in the development and implementation of new regulatory guidance.  Paul is an Expert to the British Pharmacopoeia Commission.  He is an experienced and accomplished Lecturer.

Formerly, Paul worked for the generic sector of the pharmaceutical industry in Europe in a variety of senior board level roles covering drug regulation, pharmacovigilance and formulation development and he was a Pharmaceutical Assessor at the MHRA.

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 Learn from these respected scientists with their amazing collection of experience and expertise!  Network with them at training sessions, ask the questions you puzzle over and boost your knowledge, understanding, competences and confidence.

By the way, the title at the top of this blog post is my prediction of your feedback comments after you have completed one or both of my Summer Courses in London!

Mike Robertson

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CTD Module 3 Training Course – The Pharmaceutical Dossier

30 September – 1 October 2010, The Legacy Falcon Hotel, Stratford-upon-Avon, UK

[Currently there are only 4 delegate places remaining so please email admin@pharmaqmtraining.eu to check availability before booking online]

In our CTD Module 3 course you will learn about the 4 current ways in which a Marketing Authorisation (MA) applicant can provide information to the authorities about the synthesis (GMP or otherwise), control and (sometimes) the stability of the Drug Substance.  Delegates will also learn about which methods do not apply in certain specific cases.  Not only are there requirements but sometimes there are additional options.

You will also learn about the many, key regulatory issues that impact on the Drug Product.

Many applicants are prone to ‘getting things wrong’ and attention will be given to common deficiencies encountered in regulatory assessments of the Drug Substance and Drug Product.

Many applicants are prone to ‘getting things wrong’ and attention will be given to common deficiencies encountered in regulatory assessments of the Drug Substance.  However, some applicants get things right first time which proves that this is achievable and hopefully that is the objective to which all companies aspire.

If you want to improve your understanding of these complex issues, why not take a more detailed look at the course agenda.  It is only a small document to read now but be assured that the course is comprehensive, well rehearsed over many public appearances and has always been well received by our many previous delegates.

I hope to be able to welcome you to the two-days course at the 4-Star Legacy Falcon Hotel later this month.  Check our conference package for its amazing value!  Probably your only extras will be your travel costs!

If you want more information about PharmaQMTraining.eu, please have a look at the Introductory video here.

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CTD Module 3 – in detail

In our CTD Module 3 course you will learn about the 4 current ways in which a Marketing Authorisation (MA) applicant can provide information to the authorities about the synthesis (GMP or otherwise), control and (sometimes) the stability of the Drug Substance.  Delegates will also learn about which methods do not apply in certain specific cases.

Not only are there requirements but sometimes there are additional options.

Many applicants are prone to ‘getting things wrong’ and attention will be given to common deficiencies encountered in regulatory assessments of the Drug Substance.  However, some applicants get things right first time which proves that this is achievable and hopefully that is the objective to which all companies aspire.

If you want to improve your understanding of these complex issues, why not take a more detailed look at the course agenda.  It is only a small document to read now but be assured that the course is comprehensive, well rehearsed over many public appearances and has always been well received by our many previous delegates.

I hope to be able to welcome you to the two-days course at the 4-Star Legacy Botleigh Grange Hotel & Spa later this month.  Check our conference package for its amazing value!  Probably your only extras will be your travel costs!

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CTD Quality Module 3

The next two courses that I am running will be held in Southampton, UK in March 2010.

Today I am writing about the first course http://www.pharmaqmtraining.eu/brochures/CTD.html.  It is relevant to all medicines and concerns the content that the regulatory authorities expect to find in a Drug Product submission with regard to chemistry and pharmacy topics.  In CTD-speak, this means that the subject matter predominantly affects Modules 3, 2.3 and certain parts of Module 1.

At times, of course, the module boundaries are a little diffuse because pharmaceutical decision-making, for instance about specification setting, has to take account of data from different perspectives and sources.  There could be (from Modules 4 or 5) data to consider from classical toxicological studies regarding ‘conventional’ impurities or, often more speculatively, potential concerns about genotoxicity occasioned by knowledge either of structural alerts for materials used in chemical syntheses of intermediates or drug substance, or of real data arising from ‘less than perfect’ genotoxicity tests.  And there could be bioavailability/bioequivalence issues (from Modules 3 or 5) to consider with generic products or line extensions.

‘Chemistry & Pharmacy’ or ‘Quality’ issues are part of all Marketing Authorisation Applications (MAAs) and span a huge range of medicinal products and their components, their pharmaceutical formulation and development, methods of manufacture and control, stability and delivery systems.

Our ‘CTD Quality Module 3’ course has had the most European public appearances (I’ve lost count but it’s in double figures) of all the courses that I have designed.  Derek Calam, my co-speaker, and I have refined the course in the light of questions and other feedback from delegates and it is now comprehensive, focused on most peoples’ needs and at times group interactive.  Particularly popular are the Mini-Workshops and also the attention we give to deficiencies in companies’ MAAs.

I hope to be welcoming you to one of my courses very soon.  In my next blog, I shall tell you more about the second course!

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Pharmaceutical training

For many years I have designed and participated in training courses on pharmaceutical subjects.  The objective of these courses is to assist delegates in understanding regulatory requirements for the pharmaceutical, pre-clinical and clinical development and licensing of medicines and in appreciating the underlying science.

My career background has involved working in different roles associated with the pharmaceutical industry and drug regulation.

My personal lecturing tends to focus on Quality matters including those relating to Safety and Efficacy but I work with other lecturers to extend the training into a variety of subjects relevant to preparing the Common Technical Document (CTD) Modules 1, 2, 3, 4 and 5.

It is always difficult to be sure what subjects will appeal and what training needs are ‘in fashion’.  I would welcome comments on topics of interest for pharmaceutical training courses.

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