WHO now issues draft guidance to test suspected spurious, falsely-labelled, falsified and counterfeit medicines

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The World Health Organisation (WHO) has now issued draft guidance to test suspected spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines. It expects the industry to comment before January 10, 2017.

The regulator has stated that the national and regional regulatory authorities (NRAs) are responsible to put in norms to control production, distribution and commercialization of medical products in order to ensure their quality through rigorous regulatory oversight, including post-marketing surveillance.
Rigorous regulatory oversight of medical products throughout their life cycle is necessary to recognize and remove SFFC products and to protect the supply chain against infiltration of such products. SFFC products originate from outside the legal supply chain. It is important that NRAs control the supply chain and raise awareness of health workers and patients of risks associated with medicines from illegal sources, said WHO.

The role of WHO, through its Expert Committee on Specifications for Pharmaceutical Preparations, sets technical standards on quality assurance of pharmaceutical products, including guidance on registration, good manufacturing practices (GMP), good distribution practices (GDP) and quality control (QC) testing of medicines and other topics that are relevant to the regulatory oversight of medicines.
This document provides technical guidance on laboratory testing of samples of suspected SFFC products detected on the market of WHO Member States and related aspects of sampling and reporting.

Regulatory authorities are responsible for establishing mechanisms to detect SFFC products circulating in their territories and to remove them from the market. Suspected SFFC products can be detected using a range of approaches, including routine inspections performed by national or regional authorities and enforcement agencies, targeted risk-based surveys.
SFFC products may be identified by their fake packaging and/or by physical and chemical testing. The packaging and patient information leaflets of suspect SFFC medicines should always be examined visually and compared with samples or images of genuine products if available. Attention should be paid to any irregularities or inconsistencies, such as spelling mistakes, unusual batch numbers, unexpected or modified manufacturing or expiry dates, signs of  repacking, for example, to circumvent inspection activities, or instructions in a language that does not match the area of their distribution. Microscopy and other analytical techniques need to  be utilized for the package examination, said the regulatory authority.
In the context of law enforcement, the result of a screening test is only indicative and other analytical techniques must be applied to unequivocally confirm that an SFFC product has been detected. Documentation should be prepared with information on everything that is known about the sample, including the point of detection, the volume of suspect product found, a visual description of its packaging and the dosage units including any signs of irregularities. Further, the supply history of the product and what led to its detection including adverse effects and any other relevant information needed to be provided.

Source: 1, 2

Treat your headache and migraine at NIMHANS

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National Institute of Mental Health and Neuro Sciences (NIMHANS), Bengaluru plans to establish headache centres and train primary care physicians to treat migraine cases that are on the rise. The Institute views that migraine produces maximum disability during the productive years of life. Therefore patients should access medical attention.

Migraine is 7th in the list of causes of years of life lived with disability as per the data from Global Burden of Disease survey 2010. The condition is not a chronic disorder but starts at the age of 20-30 years in majority. It is not only more prevalent in women, but also associated with greater symptoms, higher impact and poorer quality of life than in men, Dr. Girish Baburao Kulkarni, additional professor of neurology, NIMHANS told Pharmabiz.
Now NIMHANS supported by ‘Lifting the Burden’ (LTB) and WHO, conducted a population based study among patients with 1-year prevalence of migraine. It was reported that 25 per cent of the population in Bengaluru district indicated this condition and its impact was and higher among women and those from rural areas, he added.

The purpose of this study is because of a large gap of knowledge on headache disorders from many parts of world including India. LTB is a charitable company in the UK, which along with WHO has unveiled a global campaign against headache globally. NIMHAN has actively contributed in leading the Global Campaign against Headache and its burden. The study was funded by LTB to know the prevalence of headache disorders in India.

Global prevalence is 14.7 per cent–18 per cent. The age-standardized 1-year prevalence of migraine in Bengaluru at 25.2 per cent, was well above the global average, he said.

In another study comprising 330 patients of migraine seen at NIMHANS Bengaluru, only one in six accessed appropriate treatment to prevent the recurrence, stated Dr. Kulkarni.
In an article on ‘Why suffer from migraine when you can treat it’, Dr. Kulkarni also pointed out that while a headache has troubled the humans from the dawn of civilization, migraine is the commonest disabling disorder. These headaches which are moderate to severe in intensity, with nausea, vomiting and sensitivity to light and sound make the person unable to carry routine work.
The migraine treatment consists stalling the acute headache attack and preventing its recurrence. Majority of patients do not require brain scans with CT or MRI unless the treating doctor strongly suspects another disease which may mimic migraine. Unfortunately, not many people know that migraine is a treatable condition and they need not suffer in silence and darkness. With the right medical support and slight modification in lifestyle, a migraineur can live easily with prolonged migraine free days, he said.
There are  tablets, injections, nasal or oral sprays or medicated patches. Usually analgesics like diclofenac, ibuprofen, naproxen and paracetamol helps in majority of patients. For instant relief in severe pain, a specific class of agents called as triptans are prescribed. Apart from the pain relief patient, benefits from rest, anti-vomiting and anti-vertiginous drugs, explained Dr. Kulkarni.
Around 50-80 per cent of patients suffering 3-4 attacks of severe headache per month, are seen to find relief. Other methods to reduce the migraine attack is to avoid known triggers, prevent dehydration, stress control and ensuring adequate sleep. Now NIMHANS sees the need for dedicated clinics going by the rise in cases, he said.

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Clinical Trial Registry – European Union (EUDRACT)

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Clinical Trial Registry – European Union.

The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004.

Clinical trials conducted outside the EU/EEA are included if:

  • They form part of a paediatric investigation plan (PIP), or:
  • They are sponsored by a marketing authorisation holder, and involve the use of a medicine in the paediatric population as part of an EU marketing authorisation.

The Register also provides information about older paediatric trials covered by an EU marketing authorisation.

The Register enables you to search for information in the EudraCT database . This is the database used by national medicines regulators for data related to clinical trial protocols. The data on the results of these trials are entered into the database by the sponsors themselves and are published in this Register once the sponsors have validated the data.

The EU clinical trials register has been a primary registry in the World Health Organization (WHO’s) Registry Network since September 2011 and is a WHO Registry Network data provider. It is also available on the WHO International Clinical Trials Registry Platform 

In this Register, you are able to:

  • view the description of phase II to phase IV adult clinical trials where the investigator sites are in the EU/EEA;
  • view the description of any paediatric clinical trial with investigator sites in the EU/EEA;
  • view the description of any paediatric clinical trial that is sponsored by a marketing authorisation holder and involves the use of a medicinal product covered by an EU marketing authorisation in the paediatric population including trials conducted outside the EU / EEA;
  • view the description of any trials which form part of an agreed paediatric investigation plan (PIP) including those where the investigator sites are outside the EU/EEA;
  • view the summary results of the the clinical trials mentioned above;
  • view the summary results (with a reduced set of data fields) of paediatric trials completed by 26 January 2007 covered by an EU marketing authorisation;
  • download up to 50 results (per request) in a text file (.txt).

The details in the protocol related information include: the design of the trial; the sponsor; the investigational medicine (trade name or active substance); the therapeutic areas; the status (authorised, ongoing or complete).

The details of the information of the summary results for a trial include: trial information; subject disposition; baseline characteristics; endpoints; adverse events; additional information; summary attachment(s).

What is not available?

The EU Clinical Trials Register does not: provide information on non-interventional clinical trials of medicines (observational studies on authorised medicines);

provide information on clinical trials for surgical procedures, medical devices or psychotherapeutic procedures; 

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TB Alliance, Takeda enter pact for novel TB therapies

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TB Alliance and Takeda Pharmaceutical Company Limited have entered into an agreement that further explores hits generated from a high-throughput screening programme conducted to find novel compounds to improve treatment of tuberculosis (TB). The joint research programme is funded through the Global Health Innovative Technology (GHIT) Fund, established for the purpose of promoting research and development of pharmaceutical products, vaccines and diagnostics needed for communicable diseases.

In June 2013, TB Alliance and Takeda initiated a programme to screen Takeda’s library of 20,000 proprietary compounds to identify potential candidates that showed promise to be further developed into new TB treatments. This new collaboration advances the successful hits from the screening program, which was also funded by GHIT Fund. This partnership complements TB Alliance’s existing work in advancing the pipeline for new TB drugs. For Takeda, this programme with TB Alliance is an excellent opportunity to leverage, as part of Takeda’s corporate social responsibility programme, the company’s drug discovery expertise for communicable diseases, in addition to Takeda’s focus on the oncology, gastroenterology and central nervous system therapeutic areas.

TB is the leading infectious disease killer in the world. According to the World Health Organization (WHO), 9.6 million people were infected with TB in 2014. In the same year, 1.5 million people lost their lives to the disease, 95% of whom lived in low- to middle-income countries.

Today’s existing TB treatments are complicated and require a minimum of six months of treatment, imposing a heavy burden on patients, families, and healthcare systems. Treatment for drug-resistant tuberculosis can take two years or longer and is much more expensive and complicated. Given this global health threat, new TB drugs and regimens that are simpler to administer, are of shorter duration, and can overcome drug resistance are urgently needed.

The collaboration will leverage both TB Alliance’s and Takeda’s experience, knowledge and technology to discover and pursue optimal lead compounds for intervention against TB. Through these initiatives, TB Alliance and Takeda aim to contribute to the eradication of TB and improve the health and quality of life for millions of people.

Source: 1, 2, 3

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WHO frames Global Regulatory Norms for Medical Devices and IVD

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The World Health Organization (WHO)has issued a set of draft guidelines for a global model regulatory framework for medical devices including in-vitro diagnostic devices. The regulator is seeking industry comments for the same before July 12. Indian medical device companies see the move as a step in the right direction.

According to Manoj Menon, medical device consultant who was earlier with GE Healthcare said that the guidelines were anticipated for a long time and is a welcome move. The move will help improve quality of devices and solutions substantially; remove sub-standard devices and bring in transparency. However, the regulatory body should be also geared up for speedy and quality inspections through build up of appropriate tools, infrastructure and trained manpower. A step by step approach is required to manage the large pool of devices marketed.

Medical devices require the highest material and manufacturing standards. Without medical devices, routine medical procedures from bandaging a sprained ankle, to diagnosing HIV/AIDS, implanting an artificial hip or any surgical intervention would not be possible, noted WHO in its draft guidance.

The medical devices are used in many diverse settings. It could either be on a lay person at home, paramedical staff, clinicians in remote locations and highly trained medical professional in advanced medical facility. Even for opticians and dentists, medical devices are indispensable. Such health technologies are used to diagnose illness, to monitor treatments, assist disabled persons, or intervene and treat illnesses, both acute and chronic. Today there are an estimated 5,00,000 different kinds of medical devices in the world market, separated into more than 10,000 generic devices groups.

The resources people, funds, technology and facilities available in any country for regulatory control of medical devices are limited. Generally, such resources will be allocated to support overall government policy objectives and priorities but it also reflects the characteristics of the national market for medical devices. Medical devices are barometer of public health needs, burden of disease, demographic trends, economic development among others. It also indicates the industry structure on sources of supply which covers imported versus domestic manufacture.

The WHO has pointed out that regulation of medical devices does not take place in isolation and it should be coordinated with regulation of other products like medicines, vaccines, and government policy objectives.

The WHO model recommends guiding principles, harmonized definitions and the essential elements required for effective and efficient regulation. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF).

“The model is particularly relevant for WHO member states with no or limited regulation for medical devices in place. Yet it foresees that countries will progress from basic controls towards an expanded level as their resources allow. It will also describe circumstances in which a regulatory authority may rely upon, or recognize, the work products from trusted regulatory systems providing scientific assessments, audit and inspection reports or WHO pre-qualification,” stated the draft guidance.

The draft also indicated that there are limitations to the Global Model Regulatory Framework for Medical Devices including IVDs. Therefore the model provides a general approach and cannot provide country -specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it provides references to relevant documents. It does not detail responsibilities of manufacturers, distributors and healthcare professionals, who have roles to assure quality, safety and performance of medical devices.

Source : Pharmabiz