Category Archives: Other

The term big data refers to tremendously large sets of information which involve specific computational tools to enable their examination and exploitation. These data might come from electronic health records from millions of patients, genomics, social media, clinical trials or impulsive adverse reaction reports, to name just a few. The massive volume of data has the potential to contribute suggestively to the way the assistances and risks of medicines are evaluated over their entire lifecycle.

Together with the heads of the national competent authorities in the European Economic Area (EEA), known as Heads of Medicines Agencies (HMA), the European Medicines Agency (EMA) has established a new task force to explore how medicines regulators in the EEA can use big data to provision research, innovation and robust medicines development in order to benefit human and animal health.

The task force, chaired by the Danish Medicines Agency and EMA, is composed of experienced staff from medicines regulatory agencies in the EEA. Their efforts will be complemented on an ad hoc basis by external experts in big data collection analysis.

The group has agreed a number of actions for the next 18 months. These include:

• planning foundations and features of big data;
• exploring the potential applicability and influence of big data on medicines regulation and emerging endorsements on necessary changes to regulation, regulatory guidelines or data security requirements;
• formation of a roadmap for the growth of big data aptitudes for the assessment of applications for marketing authorizations or clinical trials in the national proficient specialists;
• Teamwork with other regulatory authorities and partners outside the EEA to consider their understandings on big data enterprises.

Dated: 23^rd March 2017

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/03/news_detail_002718.jsp&mid=WC0b01ac058004d5c1

NHS Digital has circulated the Summary Care Record (SCR) usage calculator tool to support community pharmacy contractors in checking and aggregate their SCR usage.

The Quality Payments scheme, which measures each appropriate pharmacy against quality standards and awards points for each one fulfilled will be a key factor in incapacitating the pharmacy cuts.

Use of the Summary Care Record accounts for 10% of Quality Payments points over the year, meaning it could be worth up to £1,280 per pharmacy.

According to NHS England’s quality criteria regulation, pharmacists will need to meet the SCR quality criterion, which entails contractors to be able to validate on the day of the review, a total increase in access to SCR from period one to two.

For the 28 April 2017 review point, period one is from Monday 27 June 2016 to Sunday 27th November 2016; and period two is from Monday 28 November 2016 to Sunday 30 April 2017.

The calculator will show the number of times a pharmacy has viewed the SCR in period 1 and period 2. And will be updated every Thursday to show the latest figures.

Dated: 10^th March 2017

http://www.thepharmacist.co.uk/news/latest-news/quality-payments-calculate-your-scr-usage/

Officials in the European Union (EU) and the United States (US) have decided to start assessments of manufacturing sites for human medicines directed in their particular areas on both sides of the Atlantic.

The contract will enable both the EU authorities and the FDA to make better use of their assessment funds to help them to concentrate on other parts of the world where active pharmaceutical ingredients (APIs) and medicines for the EU or US markets are manufactured. This will ensure that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been produced. Around 40% of finished medicines marketed in the EU come from overseas and 80% of the manufacturers of APIs for medicines available in the EU are located outside the Union.

Each year, national proficient authorities from the EU and the US Food and Drug Administration (FDA) inspect many production sites of medicinal products in the EU, the US and elsewhere in the world, to certify that these sites operate in compliance with good manufacturing practice (GMP). Under the new agreement, EU and US regulators will rely on each other’s assessments in their own areas. In future, the need for an EU authority to inspect a site located in the US, or vice versa, will be partial to remarkable conditions.

In the EU, inspections of manufacturing sites are carried out by national proficient authorities from EU Member States. The European Medicines Agency plays an important role in directing these activities in association with Member States.

The contract is reinforced by strong evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission, EU national competent authorities, EMA and the US FDA have been auditing and evaluating the respective managerial systems since May 2014, and have worked closely together to reach this agreement.

The agreement is an extension to the EU-US MRA which was signed in 1998 but is not yet executed. Many provisions of the agreement have already entered into force and others will enter into force on November 1, 2017. By that date, the EU will have completed its valuation of the FDA and the FDA is likely to have accomplished its valuation of at least eight EU Member States, and will be progressively prolonged to all Member States.

Dated:2^nd March 2017

The European Medicines Agency (EMA) is informing about a potential increased risk of lower limb amputation in patients taking the SGLT2 inhibitors canagliflozin, dapagliflozin and empagliflozin used for type 2 diabetes.

Patients taking these medicines are reminded to check their feet regularly and follow their doctor’s advice on routine precautionary foot care. They should also tell their doctor if they notice any wounds or discoloration, or if their feet are tender or painful.

The review of SGLT2 inhibitors was impelled by an increase in lower limb amputations (mostly affecting the toes) in patients taking canagliflozin in two clinical trials, CANVAS and CANVAS-R. The studies, which are still ongoing, involved patients at high risk of heart problems and matched canagliflozin with placebo (a dummy treatment).

All patients with diabetes (especially those with poorly controlled diabetes and problems with the heart and blood vessels) are at higher risk of infection and ulcers (sores) which can lead to amputations. The mechanism by which canagliflozin may increase the risk of amputation is still unclear.

A rise in lower limb amputations has not been seen in studies with other medicines in the same class, dapagliflozin and empagliflozin. However, data available to date are limited and the risk may also apply to these other medicines.

Further data are anticipated from ongoing studies with canagliflozin, dapagliflozin and empagliflozin.

A warning of the potential increased risk of toe amputation will be included in the recommending information for these medicines. For canagliflozin, the commending information will also list lower limb amputation as an uncommon side effect (occurring in between 1 and 10 patients in 1,000). Doctors may consider stopping treatment with canagliflozin if patients develop significant foot complications such as infection or skin ulcers.

The review of SGLT2 inhibitors was approved out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC approvals have now been certified by the Committee for Medicinal Products for Human Use (CHMP), and will be sent to the European Commission for a final legally-binding decision valid throughout the EU.

Dated: 24 Feb 2017

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/02/news_detail_002699.jsp&mid=WC0b01ac058004d5c1

At its February meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) suggested the permitting of a marketing authorization in the European Union (EU) for Cytopoint. This is a solution for injection containing the new active substance lokivetmab, the first monoclonal antibody in a veterinary medicine in the EU. It is proposed for the treatment of dogs with atopic dermatitis, a common allergic skin disease.

A monoclonal antibody (mAb) is an immune protein that identifies and impasses to a definite target protein. Lokivetmab is a caninised mAb developed by biotechnology that specifically targets and constrains canine interleukin-31 (IL-31), an immune protein that plays an important role in atopic dermatitis.

In dogs with this disease, the immune system reacts improperly when the animal comes in contact with allergens found in the environment causing itchy skin. Once the dog’s skin gets damaged by scratching and rubbing, secondary bacterial and yeast infections may develop as well.

The effectiveness of this medicine was assessed in a number of controlled laboratory and clinical studies. The data showed that treatment with Cytopoint reduced itching and the severity of skin disease in dogs receiving the medicine at the proposed dose of 1 mg/kg.

Cytopoint starts working within eight hours after administration and the effect lasts for up to 28 days. It comes in four different dosage forms (10, 20, 30 and 40 mg/ml) for administration to dogs of varying bodyweight.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/02/news_detail_002696.jsp&mid=WC0b01ac058004d5c1

Dated: 17^th Feb 2017

The European Network of Pediatric Research at the European Medicines Agency will hold its ninth annual workshop on 16 May 2017 in London, UK. The main objective of the workshop is to bring important stakeholders together to discuss necessities, hurdles and prospects for high-quality clinical studies in children.

Among the highlights of this year’s workshop are the current struggles to maximize collaboration between the European Union and the United States to facilitate global pediatric trials and medicine developments.

The first day of the workshop will be open to all stakeholders comprising:

• Patients/parents
• Organizations,
• Regulators
• Enpr-EMA network representatives
• Academia
• Clinical investigators and representatives from the pharmaceutical industry for pediatric studies.

Participants will hear about Enpr-EMA’s activities to substitute high-quality research in pediatric medicine and will be invited to share their views on the successes made so far and the way forward.

Registration for the first day of the workshop is open until 28 April 2017.

The second day of the workshop is kept for discussions among the members of Enpr-EMA and the Enpr-EMA organizing group. The organizing group will define significances for 2017-2018 based on the feedback received from stakeholders.

Enpr-EMA was set up to help the conduct of clinical studies in children. It is an umbrella network of 39 national and international networks known for their experience in pediatric research. It acts as a platform for sharing good practices.

Dated :9^TH Feb 2017

The European Medicines Agency (EMA) has published clinical data for two further medicines on its clinical data website. This leads to the launch of the website on 20 October 2016 and is in link with the Agency’s policy on the publication of clinical data.

These are the first clinical data published supporting an application that was consequently reserved. The clinical data for Aripiprazole Mylan relate to a withdrawn application for a marketing approval for a generic product to treat schizophrenia, and to stop and treat moderate to severe manic episodes in patients with bipolar I disorder.

Palonosetron Hospira is a generic product designated to stop nausea and vomiting initiated by chemotherapy.

Both medicines have been evaluated mentioning to information available on the effectiveness and protection of their active materials present in the respective sanctioned ‘reference medicines’. For more information on generic medicines see Questions and answers on generic medicines.

In future, the Agency will publicize clinical data publication under this policy on its commercial website on a case-by-case basis only. EMA will continue to highlight the publication of new clinical data on its clinical data website.

Dated: 1^st Feb 2017

The European Medicines Agency (EMA) has suggested that medicines comprising a combination of dienogest 2 mg and ethinylestradiol 0.03 mg can remain to be used to treat acne when proper treatments applied to the skin or antibiotics taken by mouth have not worked. However, these medicines, which are also permitted as hormonal contraceptives, should only be used in women who choose oral contraception.

Having evaluated the existing data on the effectiveness of the combination in the treatment of acne, EMA’s Committee for Medicinal Products for Human Use (CHMP) determined that there is adequate proof to sustenance its use in moderate acne. Regarding the threat of side effects, the CHMP measured that the available data do not raise any new safety concern. The known risk of venous thromboembolism (VTE or blood clots in veins), which can occur with all combined hormonal contraceptives, is considered low. However, the data on the risk with dienogest/ethinylestradiol are not adequate to assess how it compares with other contraceptives and further data are still awaited.

As the detected benefits of dienogest/ethinylestradiol in the treatment of acne, the potential risk of VTE and the nature of the disease, the CHMP concluded that this combination should only be used after certain other treatments have failed, and only when oral contraception is chosen. The CHMP also recommended that women should be evaluated by their doctor 3 to 6 months after starting treatment and periodically subsequently to review the need for continuation of treatment.

27th Jan 2017

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/01/news_detail_002685.jsp&mid=WC0b01ac058004d5c1

European regulators are active to give a quick review of AbbVie’s investigational, pan-genotypic procedure of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the cure of chronic hepatitis C (HCV) in all major genotypes.

According to the firm, the G/P procedure could deliver a shorter, eight week, once-daily, ribavirin-free cure option for the preponderance of HCV patients without cirrhosis and a supplementary treatment alternative to patients with compensated cirrhosis (Child-Pugh A).

The treatment is also projected to look forward the needs of patients with detailed treatment trials, such as those with severe chronic kidney disease (CKD) and those not treated with previous direct-acting antiviral (DAA) treatment.

The application comprises data from eight registrational studies in AbbVie’s G/P clinical growth programme, concerning more than 2,300 patients across all main HCV genotypes and special populations, which was intended to consider a faster path to virologic cure for all foremost genotypes and with the aim of covering areas of sustained unmet need.

According to AbbVie’s chief scientific officer Michael Severino,”We are contented at the prospective of our investigational, pan-genotypic regimen and that it has been approved enhanced valuation by the EMA. We will work closely with the EMA as we continue our assurance to possibly offer a treatment for as many people living with HCV as possible”.

Date: 24th January 2017

http://www.pharmatimes.com/news/speedy_eu_review_for_abbvies_pan-genotypic_hep_c_therapy_1184944

Provisional marketing authorization (CMA) can speed up access to medicines for patients with unmet medical needs. Since 2006, a total of 30 medicines have received a provisional marketing authorization. Medicines that were approved a CMA target seriously enervating or life-threatening conditions such as HIV infection, breast cancer, and severe epilepsy in infants or multi-drug resistant tuberculosis. 14 were orphan medicines, providing patients suffering from rare diseases with new treatment options. These are some of the findings of a report by the European Medicines Agency (EMA) to mark ten years of experience with CMA.

EMA’s report is a wide-ranging investigation of the positive influence this important tool has had in providing early access to new medicines for patients who formerly had no or only substandard treatment options. It emphases on how CMAs are approved or rejected and later converted into normal marketing authorizations. It also examines the type, extent and timing of data provided to support these decisions.

Provisional marketing authorization is one of the implements available to regulators to support the growth of and early access to medicines that address unmet medical needs of patients in the European Union (EU). It permits the approval of medicines if the public health assistance of their immediate availability to patients outweighs the risk of an authorization on the basis of less inclusive data than normally required. Over a period of 10 years, no medicine with a CMA had to be repealed or adjourned.

A CMA is effective for one year. As part of the authorization, the company is indulged to carry out further studies to obtain complete data. EMA’s Committee for Medicinal Products for Human Use (CHMP) evaluates the data generated by these specific post-authorizations requirements at least annually to guarantee that the balance of benefits and risks of the medicine remains positive. At the end of its valuation, the Committee recommends either the renewal or not of the CMA or its alteration into a standard marketing authorizations.

According to EMA’s analysis, marketing authorizations holders comply with the specific responsibilities forced by the Agency. More than 90% of completed precise responsibilities did not result in major changes of scope and about 70% of specific obligations did not need an extension to the initially stated timelines.

The report shows that it took an average of four years to generate the additional data needed and to convert a CMA into a full marketing authorization. This means that patients with life-threatening or seriously incapacitating conditions can access promising medicines earlier.

The report also personifies the data on which CMAs have been granted and the additional data generated through specific obligations. This information could be of interest for those developing medicinal products, as well as patients, pricing and reimbursement bodies and other stakeholders.

The report also categorizes a number of possible areas for expansion. These comprise:

• future planning of CMAs and early dialogue with EMA to support the generation of high-quality data, timely discussion of additional post-authorization studies and their possibility, and better data generation for accomplishment of explicit obligations;
• Appealing other stakeholders involved in bringing a medicine to patients, in particular Health Technology Assessment bodies, to help the generation of all data needed for decision-making through one development programme.

The full report is available together with an infographic that highlights the important results of this study. The publication of EMA’s report emphasizes the Agency’s commitment to transparency.

It responds to discussions in the European Commission’s expert group on Safe and Timely Access to Medicines for Patients (STAMP), which emphasized interest in accepting the experience of conditional marketing approvals in the EU.

Date:23 Jan, 2017

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/01/news_detail_002680.jsp&mid=WC0b01ac058004d5c1