News & Events
GMP: EU GMP Non-Compliance Report might lead to FDA Import Stop in future
The new MRA Agreement between the EU and the USA on the mutual recognition of GMP inspections is being discussed in depth. One shouldn’t conclude though that the inspection pressure would decrease now because of the recognition of EU inspections. There is a series of exceptions to look out for. The FDA will first ask […]
GMP: Packaging: Pharmeuropa Draft Chapters regarding PVC
A draft of Ph. Eur. chapter 3.1.13. Plastic additives has been published for comment in Pharmeuropa 29.2. The chapter has been revised following the identification of di(2-ethylhexyl)phthalate as a substance of very high concern (SvHC) according to the criteria of Article 57 of regulation (EC) 1907/2006 (REACH). http://www.gmp-compliance.org/gmp-news/packaging-pharmeuropa-draft-chapters-regarding-pvc
GMP: GCP: EMA Draft Guideline relating to the Trial Master File
In April 2017 the European Medicines Agency (EMA) has released a draft guideline on good clinical practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials. The draft has been adopted by the GCP Inspectors Working Group (GCP IWG). The public consultation period has started […]
RAPS: FDA Offers its Views on Medical Device Trials
Officials from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) took to the New England Journal of Medicine on Thursday to explain the wide array of clinical trial designs and data sources that may be used to support the safety and effectiveness of medical devices. https://www.raps.org/News-and-Articles/News-Articles/2021/3/FDA-offers-real-world-evidence-examples-in-device
RAPS: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (6 April 2017)
EMA Drafts Guidelines on Controlling Against False Positives in Clinical Trials.The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials. The text deals with how to mitigate the risk of false positives arising when clinical trials look at multiple treatment groups and endpoints. https://www.raps.org/News-and-Articles/News-Articles/2017/4/European-Regulatory-Roundup-EMA-Drafts-Guidelines
RAPS: Biosimilars in the EU: New IMS Report Shows Savings Through Competition
A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low.The report looks at the six classes of medicines in which biosimilars are approved, including epoetin, granulocyte-colony stimulating factor, human growth hormone (HGH), anti-tumor necrosis […]
EMA: New guide on biosimilar medicines for healthcare professionals
The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. Biosimilars are biological medicines that are highly similar in all essential aspects to a biological medicine that has already been authorised.
Dopuszczenie do obrotu dla produktu Neoparin Multi
Z przyjemnością informujemy, że SciencePharma uzyskała pozwolenie na dopuszczenie do obrotu dla produktu Neoparin Multi (Enoxaparinum natricum). http://www.sciencepharma.zaler.pl/pl/neoparin
Dopuszczenie do obrotu dla produktu Neoparin Forte
Z przyjemnością informujemy, że SciencePharma uzyskała pozwolenie na dopuszczenie do obrotu dla produktu Neoparin Multi (Enoxaparinum natricum).
URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on the initiation of the review on conducting research by the company Micro Therapeutic Research Labs in India
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on the initiation of the review on conducting research by the company Micro Therapeutic Research Labs in India. https://www.urpl.gov.pl/pl/informacja-z-dnia-03012017-r-w-sprawie-rozpocz%C4%99cie-przegl%C4%85du-dotycz%C4%85cego-prowadzania-bada%C5%84-przez
URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on confirmation by EMA recommendation to carry out tests to detect hepatitis B among patients treated with antir
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on confirmation by EMA recommendation to carry out tests to detect hepatitis B among patients treated with antiretroviral agents acting directly. http://www.urpl.gov.pl/pl/informacja-z-dnia-03012017-r-w-sprawie-potwierdzenia-przez-ema-zalecenia-przeprowadzania-test%C3%B3w
RAPS: FDA Warns Chinese Drugmaker for Refusing Inspection, Unsanitary Conditions
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 8 December to China-based Baoying County Fukang Medical Appliance with six violations. The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 8 December to China-based Baoying County Fukang Medical Appliance with six violations – See […]