Более 100 фармпроизводственных площадок из Индии подтвердили в Украине соответствие требованиям GMP | Последние новости сегодня в мире здоровья



Более 100 фармпроизводственных площадок из Индии подтвердили в Украине соответствие требованиям GMP
Более 100 фармпроизводственных площадок из Индии подтвердили в Украине соответствие требованиям GMP
По состоянию на начало июня 104 фармацевтические производственные площадки из Индии подтвердили в Украине соответствие требованиям надлежащей производственной практики (GMP). Как сообщили агентству "Интерфакс-Украина" в Ассоциации индийских фармацевтических производителей (IPMA) со ссылкой на данные Государственной службы по лекарственным средствам и контролю за наркотиками (Гослекслужба), в настоящее время действующими в Украине являются 72 заключения, которые ведомство выдало для заявителей из Индии на основании сертификатов, выданных регуляторными органами стран-участников PIC/S относительно соответствия условий производства лекарственных средств требованиям GMP и c целью применения в Украине. Кроме того, в настоящее время действующими являются 32 сертификата соответствия условий производства лекарственных средств требованиям GMP, которые были выданы заявителям из Индии Гослекслужбой после соответствующих выездных инспекционных проверок на заводы в Индии. Эксперты Гослекслужбы в настоящее время обрабатывают еще 18 заявок на получение таких сертификатов. Кроме того, в работе Гослекслужбы находятся девять заявлений на подтверждение соответствия GMP от заявителей из Индии. "Значение индийского фармпроизводства признано Всемирной организацией здравоохранения (ВОЗ), поскольку индийские генерические лекарственные средства позволяют существенно снизить стоимость лечения", - подчеркнул представитель ВОЗ в Индии Хенк Бедекам (Henk Bekedam). IPMA (Indian Pharmaceutical Manufacturer’s Association) объединяет индийских фармацевтических компаний-производителей, соответствующих высоким международным стандартам: US FDA (США), UK MHRA (Великобритания), МСС (Южная Африка), TGA (Австралия), WHO GMP (ВОЗ), GMP (Украина), которые имеют представительства в Украине. Система сотрудничества по фармацевтическим инспекциям (The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, PIC/S), объединяет 44 субъекта (в том числе более 30 регуляторных органов разных государств) более чем в 30 странах.
    2017-06-19 15:11:39


How to stop doctor brides from dropping out in Pakistan
How to stop doctor brides from dropping out in Pakistan
Many female doctors in Pakistan drop out when they start a family. Theres a new scheme to help them continue in practice by doing online video clinics on their laptops.
    2017-08-22 01:09:08


Solar eclipse 2017: What you need to know
Solar eclipse 2017: What you need to know
A few tips on the rare cosmic event, which last stretched across the US coast to coast 99 years ago.
    2017-08-21 18:39:43


Matt Dawsons life changed by a tick bite
Matt Dawsons life changed by a tick bite
A bacterial infection spread through the former England rugby players body after he was bitten.
    2017-08-21 15:53:34


Ashbrooke Care Home closed over serious risk to life
Ashbrooke Care Home closed over serious risk to life
Ashbrooke Care Home was closed after an unannounced inspection found systemic care failings.
    2017-08-21 15:09:38


Safer Downs syndrome test to be introduced in Wales
Safer Downs syndrome test to be introduced in Wales
The new test - which has a reduced risk of miscarriage - will be offered from next year.
    2017-08-21 14:12:03


Glasgow School of Art project personalises prosthetic limbs
Glasgow School of Art project personalises prosthetic limbs
A group of artisans are working with amputees in an effort to make artificial limbs more personal.
    2017-08-21 10:10:45


Masks for smear test patients in Thailand
Masks for smear test patients in Thailand
A health clinic in Thailand is handing out masks to encourage more women to attend their cervical smear tests.
    2017-08-21 02:39:45


Dad gets tattoo of brain shunt after daughters surgery
Dad gets tattoo of brain shunt after daughters surgery
Chloe Hickenbottom-Marriott says she doesnt feel lonely any more after her dads show of support.
    2017-08-21 02:39:42


Stephen Hawking: I wouldnt be here without the NHS
Stephen Hawking: I wouldnt be here without the NHS
The scientist backed the NHS in a speech that was critical of government policy and Jeremy Hunt.
    2017-08-20 03:39:44


How to get up mountains in a wheelchair
How to get up mountains in a wheelchair
Michelle, who has multiple sclerosis, is going on a trek in the Lake District for the first time in more than 10 years.
    2017-08-19 10:10:12


Mum leaves random notes in York for new mothers
Mum leaves random notes in York for new mothers
The letters offer mums a chance to take a second for themselves.
    2017-08-19 10:10:09


Stephen Hawking: Im worried about the future of the NHS
Stephen Hawking: Im worried about the future of the NHS
Cambridge professor criticises health secretary and warns about role of private sector in the NHS.
    2017-08-18 21:09:57


Calories in popular foods must be cut, say health officials
Calories in popular foods must be cut, say health officials
Health officials target pizzas, burgers and ready meals to help tackle child obesity in government drive.
    2017-08-18 02:09:25


Peanut allergy treatment lasts up to four years
Peanut allergy treatment lasts up to four years
Four years after children in a study took the oral treatment, 70% had no allergic reaction to peanuts.
    2017-08-17 16:11:02


Maternity must improve at baby-deaths hospital trust
Maternity must improve at baby-deaths hospital trust
Progress is made at the Shrewsbury and Telford trust but maternity services must improve, the CQC says.
    2017-08-16 11:10:00


Time spent frail in old age doubles
Time spent frail in old age doubles
More care homes are needed as an ageing population puts pressure on services, researchers suggest.
    2017-08-16 02:09:35


Reunion after baby umbilical cord drama in Derbyshire
Reunion after baby umbilical cord drama in Derbyshire
Baby Ella was struggling to breathe after getting her neck caught on the umbilical cord during her birth.
    2017-08-15 16:10:23


Drug deaths in Scotland rose by 23 процентов in 2016
Drug deaths in Scotland rose by 23 процентов in 2016
The total number of fatal overdoses was recorded at 867 in 2016 - nearly a quarter higher than 2015.
    2017-08-15 16:10:10


Plants hijacked to make polio vaccine
Plants hijacked to make polio vaccine
A breakthrough could lead to easier, faster and cheaper vaccines.
    2017-08-15 12:39:44


Japanese fungus spreading in UK hospitals
Japanese fungus spreading in UK hospitals
More than 200 patients have been infected, but none has died, Public Health England confirms.
    2017-08-15 12:10:06


Why Scottish babies might start sleeping in cardboard boxes
Why Scottish babies might start sleeping in cardboard boxes
It is hoped that the cardboard boxes will help reduce cot deaths in Scotland.
    2017-08-15 08:39:28


NHS cyber-defender Marcus Hutchins pleads not guilty in US
NHS cyber-defender Marcus Hutchins pleads not guilty in US
Marcus Hutchins was arrested on 2 August on a trip to cyber-security conferences in Las Vegas.
    2017-08-14 18:39:33


Anger and hatred can make us feel happy, says study
Anger and hatred can make us feel happy, says study
People have higher life satisfaction if they feel emotions they desire - even if they are unpleasant.
    2017-08-14 16:10:30


Yemen cholera epidemic: Cases exceed 500,000 in four months
Yemen cholera epidemic: Cases exceed 500,000 in four months
The overall caseload has declined since early July, but 5,000 people a day are still being infected.
    2017-08-14 14:09:52


Flying doctors service extended to cover north Wales
Flying doctors service extended to cover north Wales
Specialist doctors are to join Wales Air Ambulance crews to treat seriously injured patients faster.
    2017-08-14 09:40:52


Medevac E.coli woman Caroline Hope dies in hospital
Medevac E.coli woman Caroline Hope dies in hospital
Teacher Caroline Hope became infected while receiving cancer treatment in Turkey.
    2017-08-14 09:40:49


Vulnerable children not in crisis are left in limbo
Vulnerable children not in crisis are left in limbo
Action for Children estimates 140,000 children referred to social services do not get the help they need.
    2017-08-14 09:40:42

Что будем читать?

Список новостей
Прокрутить вверх