Monthly Archives: September 2010

EMA announce International Workshop on the Ethical and Good Clinical Practice (GCP) Aspects of Clinical Trials Conducted in Third Countries

EMA announce International Workshop on the Ethical and Good Clinical Practice (GCP) Aspects of Clinical Trials Conducted in Third Countries

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The workshop will enable participants to discuss and provide feedback on the ‘Draft reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorization applications to the EMA’ which was released for public consultation on the Agency’s website in May 2010. The workshop complements this consultation process. Conclusions from the workshop and copies of the presentations will be subsequently published in a short report. Please note that registration for the workshop is now closed.

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EMA Announce Workshop on Nano-Medicines

EMA Announce Workshop on Nano-Medicines

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On 2-3 September 2010, EMA hosted the first international scientific workshop on nanomedicines. Some 200 European and international participants from 27 countries including Australia, Canada, India, Japan and the United States discussed benefits and challenges arising from the application of nanotechnologies to medicines. Participants included representatives from patients’ organisations, health care professionals’ organisations, academia, regulatory authorities and pharmaceutical industry.

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EMA Publishes Assessment report on Valeriana officinalis L., radix and Humulus lupulus L., flos

EMA Publishes Assessment report on Valeriana officinalis L., radix and Humulus lupulus L., flos

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Herbal preparation(s) The phytochemical composition of both valerian root and hop strobiles and their preparations have amply been discussed in the assessment reports on valerian root and hop strobiles (EMEA/HMPC/167391/2006 and EMEA/HMPC/513618/2006, respectively).

Posology: As an aid to sleep: adults and adolescents 2 coated tablets in the evening, children from 6-12 years of age (when recommended by a doctor) 1 coated tablet. Restlessness, nervousness: adults and adolescents 1-3 x daily 1 coated tablet, children from 6-12 years of age (when recommended by a doctor) 1-2 x daily 1 coated tablet.

Previous documents state a DER of the valerian extract of 5:1 and of the hops extract of 5.5:1. It is not clear whether the company changed the specification of the extracts recently or they made a correction to the actual conditions in the manufacturing process.

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Herbal preparation(s) The phytochemical composition of both valerian root and hop strobiles and their preparations have amply been discussed in the assessment reports on valerian root and hop strobiles (EMEA/HMPC/167391/2006 and EMEA/HMPC/513618/2006, respectively).

EMA Publiushes Overview of comments received on Community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos (EMA/HMPC/132077/2010)

EMA Publishes Overview of comments received on Community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos

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Organisations and/or individuals
1 Czech Plant Commission of Ministry of Health
2 AESGP
3 EHPM

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EMA Publish Opinion on Community Herbal Monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos

EMA Publish Opinion on Community Herbal Monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos

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The HMPC, In accordance with Article 16h(3) of directive 2001/83/EC, as amended and as set out in the appended assessment report, establishes by a majority of 23 out of 28 votes a community herbal monograph on Valeriana officinalis L., radix and Humulups Lupulus L, flos.

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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 Puiblish Guidance on Q4B, Evaluation and Recommendation of Pharmacopoeial Text for Use in ICH regions, Annex 12 Analytical Sieving General Chapter

FDA Publish Guidance on Q4B, Evaluation and Recommendation of Pharmacopoeial Text for Use in ICH regions, Annex 12 Analytical Sieving General Chapter.

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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.3
This annex is the result of the Q4B process for the Analytical Sieving General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

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EMA Publish List of References Supporting the Assessment of Valeriana officinalis L., radix and Humulus Lupulus L., flos

EMA Publish List of References Supporting the Assessment of Valeriana officinalis L., radix and Humulus Lupulus L., flos

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The Agency acknowledges that copies of the underlying works used to produce this monograph were provided for research only with exclusion of any commercial purpose.
Abourashed EA, Koetter U, Brattström A. In vitro binding experiments with a valerian, hops and their fixed combination extract (Ze91019) to selected central nervous system receptors. Phytomedicine 2004; 11: 633-638
Balduini W, Cattabeni F. Displacement of [3H]N6-cyclohexyladenosine binding to rat cortical membranes by an hydroalcoholic extract of Valeriana officinalis. Med Sci Res 1989; 17: 639-640
Bos R, Woerdenbag HJ, De Smet PAGM et al. Valeriana species. In: De Smet PGMA, Keller K, Haensel R, Chandler RD (eds.): Adverse effects of herbal drugs. Vol 3, Springer-Verlag Berlin, 1998; 165-180
Brattström A. Wirksamkeitsnachweis von Phytopharmaka am Beispiel einer Hopfen-Baldrian-Kombination. Forsch Komplementärmed 1996; 3: 188-195
Brattström A. Scientific evidence for a fixed extract combination (Ze 91019) from valerian and hops traditionally used as a sleep-induced aid. Wien Med Wochenschr 2007; 157 (13-14): 367-370
Butterweck V, Brattstroem A, Grundmann O, Koetter U. Hypothermic effects of hops are antagonized with the competitive melatonin receptor antagonist luzindole in mice. J Pharm Pharmacol 2007; 59: 549-552
Cavadas C, Araújo I, Cotrim MD, Amaral T, Cunha AP, Macedo T, Fontes Ribeiro C. In vitro study on the interaction of Valeriana officinalis L. extracts and their amino acids on GABA-A receptor in rat brain. Arzneim.-Forsch./Drug Res 1995; 45/II (7): 753-755

Coxeter PD, Schluter PJ, Eastwood HL, et al. Valerian does not appear to reduce symptoms for patients with chronic insomnia in general practice using a series of randomised n-of-I trials. Complementary Therapies in Medicine 2003; 11: 215-222
Dorn M. Efficacy and tolerability of valerian versus oxazepam in non-organic and non-psychiatric insomnias: a randomized, double-blind, clinical, comparative study. Komplementaermedizin und Klassische Naturheilkunde 2000; 7: 79-84
Estrada J, Gozala F, Cecchini L, Casquette E. Contact urticaria from hops (Humulus lupulus) in a patient with previous urticaria-angioedema from peanut, chestnut, and banana. Contact Dermat 2002; 46: 127
Flesch P. Hopfen-Baldrian-Kombination als Benzodiazepin-Ersatz? Geriatrie Praxis 1, 1997 (suppl.) 21-23
Füssel A, Wulf A, Brattström, A. Effect of a fixed valerian-hop extract combination (ZE91019) on sleep polygraphy in patients with non-organic insomnia: a pilot study. Eur J Med Res 2000; 18 (5): 385-390
Gerhauser C, Frank N. Xanthohumol, a new all-rounder? Molec Nutr & Food Res 2005; 49 (9): 821-823
Göggelmann W, Schimmer O. Mutagenic activity of phytotherapeutical drugs. In: Knudsen I, editor. Genetic Toxicology of the Diet. New York, Alan R. Liss, 1986; 63-72
Grundmann O, Brattström A, Koetzer U, Butterweck V. Hypothermic effects of hops could antagonise with the competitive melatonin receptor antagonist luzindole. Planta Medica 2006; 72 (11): 1065, 281
Hendriks H, Bos R, Woerdenbag HJ, Joster AS. Central nervous depressant activity of valerenic acid in the mouse. Planta Med 1985; 51: 28-31
Jacobs BP, Bent S, Tice JA, et al. An internet-based randomized, placebo-controlled trial of kava and valerian for anxiety and insomnia. Medicine 2005; 84: 197-207
Kamm-Kohl AV, Jansen W, Brockmann P. Moderne Baldriantherapie gegen nervöse Störungen im Senium. Med Welt 1984; 35: 1450-1454
Koetter U, Schrader E, Käufeler R, Brattström A. A randomized, double-blind, placebo-controlled, prospective clinical study to demonstrate clinical efficacy of a fixed valerian hops extract combination (Ze 91019) in patients suffering from non-organic sleep disorder. Phytoher Res 2007; 21: 847-851
Lataster MJ, Brattström A. Die Behandlung von Patienten mit Schlafstörungen. Wirksamkeit und Verträglichkeit von Baldrian-Hopfen-Dragees. Notabene Medici 1996; 4: 182-185
Leathwood PD, Chauffard F, Heck E, Munoz-Box R. Aqueous extracts of valerian root (Valeriana officinalis L.) improves sleep quality in man. Pharmacol Biochem Behav 1982; 17: 65-71
Mennini T, Bernasconi P, Bombardelli E, Morazzoni P: In vitro study on the interactions of extracts and pure compounds from Valeriana officinalis roots with GABA, benzodiazepine and barbiturate receptors in rat brain. Fitoterapia 1993; 64 (4): 291-300
Milligan S, Kalita J, Pocock V, Heyerick A, De Cooman L, Rong H, De Keukeleire D. Oestrogenic activity of the hop phyto-oestrogen, 8-prenylnaringenin. Reproduction 2002; 123: 235-242
Morin CM, Koetter U, Bastien C, Wane JC, Wooter V. Valerian-hops combination and diphenhydramine for treating insomnia: a randomised placebo-controlled clinical trial. Sleep 2005; 28 (11): 1465-1471
Mueller-Limmroth W, Ehrenstein W. Experimental studies of the effects of Seda-Kneipp on the sleep of sleep disturbed subjects: implications of the treatment of different sleep disturbances. Med Klin 1977; 72: 1119-1125

Mueller CE, Schumacher R, Brattström A, Abourashed EA, Koetter E. Interactions of valerian extracts and a fixed valerian-hop extract combination with adenosine receptors. Life Sciences 2002; 71 (16): 1939-1949
Notter D, Brattström A, Morandell D, Polasek W. Wirksamkeit und Sicherheit eines Baldrian-Hopfen-Kombinationspräparates bei verschiedenen Schlafstörungen. Phytotherapie 2003; 3: 9-12
Ortiz JG, Nieves-Natal J, Chavez P. Effects of Valeriana officinalis extracts on [3H]flunitrazepam binding, synaptosomal [3H]GABA uptake and hippocampal [3H]GABA relase. Neurochem Res 1999; 24: 1373-1378
Rodenbeck A, Hajek G. Polysomnographische Pilotstudie zur Wirkung von Hopfen/Baldrian auf den Schlaf von Patienten mit primärer Insomnie. Eine doppelblinde, randomisierte, placebokontrollierte Studie im Schlaflabor 1998, Study Report MI 9221
Romero-Jimenez M. et al. Genotoxicity and antigenotoxicity of some traditional medicinal herbs. Mut Res 2005; 147-155.
Rücker G, Tautges J, Sieck A, Wenzl H,, Graf E. Untersuchungen zur Isolierung und pharmakodynamischen Aktivität des Sesquiterpens Valeranon aus Nardostachys jatamansi DC. Arzneim.-Forsch./Drug Res 1978; 28/I (1): 7-13
Schellenberg A, Sauer S, Abourashed EA, Koetter U, Brattström A. The fixed combination of valerian and hops (Ze91019) acts via a central adenosine mechanism. Planta Med 2004; 70: 694-697
Schmitz M, Jäckel M. Comparative study for assessing quality of life of patients with exogenous sleep disorders (temporary sleep onset and sleep interruption disorders) treated with a hops-valerian preparation and a benzodiazepine drug. Wien Med Wochenschr 1998; 148: 291-298
Stevens JF, Page JE. Xanthohumol and related prenylflavonoids from hops and beer: to your good health! Phytochem 2004; 65: 1317-1330
Vonderheid-Guth B, Iodora A, Brattström A, Dimpfel W. Pharmacodynamic effects of valerian and hops extract combination (Ze 91019) on the quantitative-topographical EEG in healthy volunteers. Eur J Med Res 2000; 5: 139-144
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Vorbach EU, Goertelmeyer R, Brüning J. Therapie von Insomnien. Wirksamkeit und Verträglichkeit eines Baldrianpräparates. Psychopharmakontherapie 1996; 3: 109-115
Wegener T. Phytopharmaka zur Anxiolyse. Zur Wirkung einer Kombination von Baldrian und Hopfen bei Angstzuständen. Dt Apoth Ztg 2003; 143: 618-625
Yuan CH, Mehendale S, Yiao Y, et al: The gamma-aminobutyric acidergic effects of valerian and valerenic acid on rat brainstem neuronal activity. Anesth Anal 2004; 98: 353-358
Ziegler G, Ploch, Miettinen-Baumann A, Colle W. Efficacy and tolerability of valerian extract LI 156 compared with oxazepam in the treatment of non-organic insomnia – a randomiazed, double-blind, comparative clinical study. Eur J Med Res 2002; 7: 480-486

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FDA Publish Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in ICH regions, Annex 11, Capillary Electrophoresis General Chapter

FDA Publish Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in ICH regions, Annex 11, Capillary Electrophoresis General Chapter.

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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 Capillary Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

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FDA Publishes Guidance on Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PCTA) Catheters.

FDA Publishes Guidance on Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PCTA) Catheters.

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The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Class II Special Controls
Guidance Document for Certain Percutaneous Transluminal Coronary
Angioplasty (PTCA) Catheters.'' The guidance was developed as a special
control to support the reclassification of PTCA catheters, other than
cutting/scoring PTCA catheters, from class III (premarket approval)
into class II (special controls). This guidance describes a means by
which PTCA catheters, other than cutting/scoring PTCA catheters, may
comply with the requirement of special controls for class II devices.
Elsewhere in this issue of the Federal Register, FDA is publishing a
final rule that codifies the reclassification of this device type from
class III (premarket approval) into class II (special controls).

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FDA Publish Guidance on Developing Drugs for Acute Bacterial Skin and Skin Structure Infections

FDA Publish Guidance on Developing Drugs for Acute Bacterial Skin and Skin Structure Infections.

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The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of acute bacterial skin and skin structure infections (ABSSSI), impetigo, and minor cutaneous abscesses. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for systemic drugs to support an indication for treatment of ABSSSI, and topical or systemic drugs to support an indication for treatment of impetigo or minor cutaneous abscesses. This guidance is intended to serve as a focus for continued discussions among the Division of Anti27
Infective and Ophthalmology Products and the Division of Special Pathogen and Transplant Products, pharmaceutical sponsors, the academic community, and the public. This guidance does not address lower extremity infections in neurologically compromised patients, such as the diabetic foot infection or pressure sore infection. Currently, there are ongoing efforts in the scientific community regarding clinical trial designs and endpoints for ABSSSI. As the science of clinical trial design for this indication evolves, we expect that this guidance may be revised.

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FDA Publishes Guidance on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment

FDA Publishes Guidance on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment.

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This guidance provides recommendations for the development of direct-acting antiviral agents (DAAs) regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA) for the treatment of chronic hepatitis C (CHC) infection. For the purpose of this guidance, we define direct-acting hepatitis C virus (HCV) antivirals as agents that interfere with specific steps in the HCV replication cycle through a direct interaction with the HCV polyprotein and its cleavage products. This guidance is intended to serve as a focus for continued discussions among the review divisions, pharmaceutical sponsors, the academic community, and the public. The organization of the guidance parallels the development plan for a particular drug or biologic.

This guidance does not address the development of immune-based agents for the treatment of HCV infection such as new interferon products. Therapeutics without antiviral mechanisms intended to mitigate or reverse clinical or pathophysiological outcomes of CHC, such as prevention of hepatocellular carcinoma (HCC), reversal of fibrosis, or treatment of acute hepatitis C, are not addressed in this guidance.

Additionally, general issues of clinical trial design or statistical analyses for HCV trials are not addressed in this guidance. Those topics are addressed in the ICH guidances for industry E9 Statistical Principles for Clinical Trials and E10 Choice of Control Group and Related Issues in Clinical Trials. This guidance also does not contain details regarding nonclinical safety and toxicology studies. Such studies for direct-acting HCV antivirals generally should be conducted in standard animal models as described in the guidance for industry Nonclinical Safety Evaluation of Drug or Biologic Combinations.

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MHRA start consultation to allow student midwives access to the parenteral medicines which can be administered by registered midwives

MHRA start consultation to allow student midwives access to the parenteral medicines which can be administered by registered midwives

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The MHRA are writing to consult you, in accordance with section 129(6) of the Medicines Act 1968, on proposals to allow student midwives access to the parenteral medicines which can currently be administered by registered midwives under an exemption in medicines legislation. This would be achieved by amendments to the Prescription Only Medicines (Human Use) Order 1997 (the POM Order).

The proposals, which have been developed in consultation with the Nursing and Midwifery Council (NMC) – the statutory regulator for the nursing and midwifery professions, are intended to benefit the care of women and their babies by ensuring the provision of safe midwifery services. They will enable student midwives to gain experience in the administration of parenteral medicines ensuring they are fit to practice at the point of registration

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FDA Publishes Guidnace on Suicidality: Prospective Assessment of Accurance in Clinical Trials

FDA Publishes Guidance on Scidality: Prospective Assessment of Occurrence in Clinical Trials.

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The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidality in clinical trials of drug and biological products. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the importance of suicidality assessment in psychiatric and nonpsychiatric drug trials and the general principles for how best to accomplish this assessment during drug development.

The principles discussed in this guidance for the prospective assessment of suicidality involve actively querying patients about the occurrence of suicidal thinking and behavior, rather than relying on patients to report such occurrences spontaneously, followed by retrospective classification of events into appropriate categories. This guidance recommends a specific suicidality assessment instrument that can be used to conduct such prospective assessments and offers guidance on the use of alternative instruments. This guidance intends to serve as a focus for continued discussions among the FDA, pharmaceutical sponsors, the academic community, and the public. This guidance does not address the complex analytic issues involved in the analysis of the suicidality data that will be derived from prospective assessments of suicidality; these issues will be addressed in separate guidances.

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EMA Publishes, Guidance on centrally authorised products requiring a notification of a change for update of annexes

EMA Publishes, Guidance on centrally authorised products requiring a notification of a change for update of annexes

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On 23 July 2010 and after a consultation phase, the EMA communicated to all Parallel Distributors that it is not required to inform the EMA on changes to the labelling or leaflet related to any update of the annexes, except for those when the EMA has specifically indicated that a notification of a change is still required. The following table lists the centrally authorised products that the EMA requires to submit a notification of change before implementation due to safety or quality reasons.

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NICE Publish Guidance on Tocilizumab for the Treatment of Rheumatoid Arthritis

NICE Publish Guidance on Tocilizumab for the Treatment of Rheumatoid Arthritis.

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Tocilizumab, in combination with methotrexate, is recommended for the treatment of moderate to severe active rheumatoid arthritis in people whose rheumatoid arthritis has responded inadequately to one or more tumour necrosis factor alpha (TNF-α) inhibitors and:
• whose rheumatoid arthritis has responded inadequately to rituximab or
• in whom rituximab is contraindicated or when rituximab is withdrawn because of an adverse effect.

People who are currently receiving tocilizumab for the treatment of rheumatoid arthritis and whose circumstances do not meet the criteria described in 1.1 should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

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EMA Publish Guideline for the specifications of e-submissions of parallel distribution notification documents

EMA Publish Guideline for the specifications of e-submissions of parallel distribution notification documents

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The European Medicines Agency (hereinafter referred to as “the Agency”) is strongly encouraging Industry in different areas of our activities to move from paper to electronic submissions. The benefits of moving to e-submissions are considered to be:
• Increase efficiency.
• Facilitation of the review process with improved quality and consistency
• Minimize delays in routing and tracking and improve turnaround times.
This Guidance is intended to assist Parallel Distributors (hereinafter referred to as “PD”) with the submission of notifications or notifications of a change for parallel distribution in electronic format to the Agency.
It is highlighted that this e-submission procedure refers to the submissions of documents in electronic format and it is not intended for tracking the status of notifications. However, the system will allow some basic tracking procedures.
During the handling of notifications, the Agency will continue to exchange information via the usual electronic tools (i.e. e-mail). For example, incorrect info, validation and comments letter. Only the notice letter issued at the end of the procedure will be sent in paper format to the PD, the National Competent Authority(ies) (NCAs) and the Marketing Authorisation Holder (MAH).

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NICE Publish Guidance on the Mangement of Transient Loss of Consiousness (Blackouts) in Adults and Young People

NICE Publish Guidance on the Management of Transient Loss of Consciousness (Blackouts) in Adults and Young People.

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This guideline is about the assessment, diagnosis and specialist referral of adults and young people (aged 16 and older) who have experienced a blackout (the medical term for this is ‘transient loss of consciousness’ or TLoC for short).

TLoC is very common: it affects up to half the population in the UK at some point in their lives. TLoC may be defined as spontaneous loss of consciousness with complete recovery. In this context, complete recovery would involve full recovery of consciousness without any residual neurological deficit. An episode of TLoC is often described as a ‘blackout’ or a ‘collapse’, but some people collapse without TLoC and this guideline does not cover that situation. There are various causes of TLoC, including cardiovascular disorders (which are the most common), neurological conditions such as epilepsy, and psychogenic attacks.

The diagnosis of the underlying cause of TLoC is often inaccurate, inefficient and delayed. There is huge variation in the management of TLoC. A substantial proportion of people initially diagnosed with, and treated for, epilepsy have a cardiovascular cause for their TLoC. Some people have expensive and inappropriate tests or inappropriate specialist referral (unnecessary referral or referral to the wrong specialty); others with potentially dangerous conditions may not receive appropriate assessment, diagnosis and treatment.

There is some existing NICE guidance that relates to TLoC, including that on epilepsy, falls, dual chamber pacemakers and implantable cardioverter defibrillators. Although related guidance on conditions that may contribute to TLoC exist (particularly chapter 8 of the ‘National service framework for coronary heart disease’, and the European Society of Cardiology guidelines on syncope), there is no NICE guidance that addresses the crucial aspects of initial assessment, diagnosis and specialist referral of people who have had TLoC. People experiencing TLoC may come under the care of a range of clinicians, and the lack of a clear pathway may contribute to misdiagnosis and
inappropriate treatment.

In considering the assessment and treatment of people who have experienced TLoC, it is important to distinguish terms that describe the circumstances or nature of the episode from those that define the mechanism for loss of consciousness. Descriptive terms tend to guide further aspects of assessment, whereas the mechanism of TLoC will determine treatment. For example, ‘exercise-induced syncope’ describes the circumstances in which TLoC has occurred but does not indicate whether it was due to the
mechanical effect of structural heart disease (such as severe aortic stenosis requiring valve surgery), a cardiac arrhythmia complicating structural heart disease (requiring treatment of the structural heart disease and of the arrhythmia), or a cardiac arrhythmia that requires treatment but is either not associated with any other heart disease or is associated with other heart disease that does not in itself require treatment. Furthermore, syncope that is exercise-induced but occurs shortly after stopping exercise rather than during exercise is most likely to be vasovagal in origin. The appropriate choice of investigation will be determined by the fact that TLoC was exercise-induced
and by findings from the initial clinical assessment and electrocardiogram (ECG). The mechanism for TLoC established by these investigations will determine what treatment may be needed.

Clinical reasoning forms an important part of the process of ensuring that people who experience TLoC receive assessment, advice and treatment that is appropriate for each individual. Determination of the mechanism for TLoC in an individual requires collection of evidence (from a detailed history, from clinical assessment and from appropriate investigations), and interpretation of each piece of evidence in overall clinical context. For example, in one person a piece of evidence such as witnessed seizure activity and/or urinary incontinence may point to a diagnosis of epilepsy, but in another may be entirely consistent with ‘convulsive syncope’, where other features of the
episode indicate clearly that it was an episode of vasovagal syncope.

This guideline aims to define the appropriate pathways for the initial assessment, diagnosis and specialist referral of people who have had TLoC, so that they receive the correct diagnosis quickly, efficiently and cost effectively, leading to a suitable management plan. The approach of the Guideline Development Group was to produce a guideline in the form of an algorithm, pointing clinicians and patients towards those areas where guidance already exists (such as the guidance on epilepsy [NICE clinical
guideline 20]; an update to this guideline is expected in March 2011), and providing new guidance in other areas, namely for people with syncope.

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EMA Publishes, Community herbal monograph on Cinnamomum verum J.S. Presl (Cinnamomum zeylanicum Nees), aetheroleum

EMA Publishes, Community herbal monograph on Cinnamomum verum J.S. Presl (Cinnamomum zeylanicum Nees), aetheroleum

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended. Cinnamomum verum J. S. Presl (Cinnamomum zeylanicum Nees),  aetheroleum corticis (cinnamon bark oil)
i) Herbal substance Not applicable
ii) Herbal preparations Essential oil obtained by steam distillation from the cortex

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NICE Publish Guidlines on the Management of Hypertensive Disorders during Pregnancy

NICE Publish Guidelines on the Management of Hypertensive Disorders during Pregnancy.

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Hypertensive disorders during pregnancy occur in women with pre-existing primary or secondary chronic hypertension, and in women who develop new-onset hypertension in the second half of pregnancy.
Hypertensive disorders during pregnancy carry risks for the woman and the baby. Although the rate of eclampsia in the United Kingdom (UK) appears to have fallen, hypertension in pregnancy remains one of the leading causes of maternal death in the UK. Hypertensive disorders during pregnancy may also result in substantial maternal morbidity. A UK study reported that one-third of severe maternal morbidity was a consequence of hypertensive conditions. A study from one region of the UK reported that 1 in 20 (5%) women with severe pre-eclampsia or eclampsia were admitted to intensive care. More recently, the long-term consequences for women with a diagnosis of hypertension during pregnancy have become clear, in particular chronic hypertension and an increase in lifetime cardiovascular risk.
Hypertensive disorders also carry a risk for the baby. In the most recent UK perinatal mortality report, 1 in 20 (5%) stillbirths in infants without congenital abnormality occurred in women with pre-eclampsia. The contribution of pre-eclampsia to the overall preterm birth rate is substantial; 1 in 250 (0.4%) women in their first pregnancy will give birth before 34 weeks as a consequence of pre-eclampsia and 8–10% of all preterm births result from hypertensive disorders. Half of women with severe pre-eclampsia give birth preterm.
Small-for-gestational-age babies (mainly because of fetal growth restriction arising from placental disease) are common, with 20–25% of preterm births and 14–19% of term births in women with pre-eclampsia being less than the tenth centile of birth weight for gestation.

There is national guidance on the care of women with severe pre-eclampsia or eclampsia and on screening for hypertensive disorders during pregnancy1
This clinical guideline contains recommendations for the diagnosis and management of hypertensive disorders during pregnancy in the antenatal, intrapartum and postnatal periods. It includes recommendations for women with chronic hypertension who wish to conceive and recommendations for advice to women after a pregnancy complicated by hypertension. . However, there has been no guidance on the assessment and care of women and their babies after a diagnosis of hypertension (including the use of antihypertensive treatment) or on maternity care for women with chronic hypertension.

This guideline assumes that prescribers will use a drug’s summary of product characteristics (SPC) to inform decisions made with individual patients. Drugs for which particular attention should be paid to the contraindications and special warnings during pregnancy and lactation are marked with † and detailed in appendix D.

This guideline recommends some drugs for indications for which they do not have a UK marketing authorisation at the date of publication, if there is good evidence to support that use. Many drugs do not have a license for use specifically in pregnant women, reflecting the fact that this group is often excluded from studies.

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