News & Events
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 […]
RAPS: FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars
Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar. Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar […]
GMP: EMA issues new Guideline on “Chemistry of Active Substances”
A medicinal product authorization application requires comprehensive information on origin and quality of an active substance. What information is required was defined in two Guidelines so far: the Guideline “Chemistry of Active Substances” (3AQ5a) from 1987 and the “Guideline on the Chemistry of New Active Substances” from 2004. http://www.gmp-compliance.org/enews_05704_EMA-issues-new-Guideline-on-%22Chemistry-of-Active-Substances%22.html
FDA: Considerations in Demonstrating Interchangeability With a Reference Product
This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf
RAPS: CDRH Warns Three Foreign Medical Device Manufacturers
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China and South Korea. The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device […]
URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on guidelines for the naming of medicinal products for human use
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on guidelines for the naming of medicinal products for human use. http://www.urpl.gov.pl/pl/komunikat-prezesa-urz%C4%99du-rejestracji-produkt%C3%B3w-leczniczych-wyrob%C3%B3w-medycznych-i-produkt%C3%B3w-8