News & Events
FDA: Hypertension Indication: Drug Labeling for Cardiovascular
This guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood pressure; the labeling does not include information on the clinical benefits related to […]
MHRA: MHRA’s Interpretation of Cross Contamination & PDEs
The British inspectorate MHRA has recently published an interpretation that goes into detail on the use of health based exposure limits and explains the cases where EMA’s new concept can be applied. One essential element of that concept is EMA’s Q&A Paper describing when a product should be classified as highly active. http://www.gmp-compliance.org/gmp-news/mhras-interpretation-of-cross-contamination-pdes
MHRA: PIC/S statement to European Commission’s ATMP GMP Guideline
During the last months, we reported several times about the current activities of the EMA and European Commission relating to the new GMP Guideline document for Advanced Therapy Medicinal Products ( e.g. “European Commission: Draft Guideline GMP for ATMP open for stakeholder consultation” and “GMP for ATMP – two Public Rounds of consultation and still […]
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).