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Medicine costs have increased steeply in Russia According to research by Moscow s Higher School of Economics the pride of Russian made essential medicines increased by a staggering 28 9 in 2015 while imported drugs increased in cost by 4 9 Mental healthcare in Russia
At Teva ESG means advancing health and equity through our medicines and across our business minimizing the impact of our operations and products on the planet and dedicating ourselves to quality ethics and transparency Discover more Teva s 2020 Environmental Social and Governance ESG Progress Report
NIOSH defines a Closed System Drug Transfer Device CSTD as a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of the hazardous drug or vapor concentrations outside the system NIOSH 2004 Currently CSTDs generally follow one of two design concepts using either
The Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte BfArM is an independent federal higher authority within the portfolio of the Federal Ministry of Health
Drugs provides accurate and independent information on more than 24 000 prescription drugs over the counter medicines and natural products This material is provided for educational purposes only and is not intended for medical advice diagnosis or treatment Data sources include IBM Watson Micromedex updated 2 Aug 2021 Cerner Multum updated 3 Aug 2021 ASHP updated 30 July 2021
Personal protective equipment PPE is the last line of defense against exposure to hazardous drugs HDs when compounding A recent survey of 183 pharmacy practitioners compounding HDs conducted by Boiano in the Journal of Occupational and Environmental Hygiene 2015 revealed that 47 did not double glove and 10 did not wear any gloves
A Q A guide to pharma medical device regulation in South Korea covering the healthcare bodies and competent authorities marketing authorisation defective and
The exclusion for drug and medical equipment manufacturers may not be permanent The HHS wants to study the issue and figure out which types of devices drugs or companies should get an exemption The device industry officials say they expect to get some type of safe harbor in the final rule
Patent protection Without adequate and effective patent protection the research based pharmaceutical industry would not exist Fortunately the standards for protection of intellectual property in the United States Europe and Japan are for the most part adequate
Reference Id PHARMATUTOR ART 1316 Introduction As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive regulatory agencies are being established in various countries across the globe Regulatory authority and organizations are responsible in effective drug regulation required to ensure the safety efficacy and quality of drugs
Federal Institute for Drugs and Medical Devices The Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte BfArM is an independent federal higher authority within the portfolio of the Federal Ministry of Health At the BfArM roughly 1 000 employees are involved in licensing improving the
Getty Images Russia s Sputnik V coronavirus vaccine gives around 92 protection against Covid 19 late stage trial results published in The Lancet reveal It has also been deemed to be safe
No Prescription For Consumer Protection Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich It doesn t fit and the combination isn t very appetizing FDA regulated manufacturers of prescription medical products
Patent protection and the market exclusivity that comes with it help to ensure a return on investment A patent holder has the right to exclude others from making using and selling the patented invention for a defined period Therefore patented drugs are temporarily safe from the competition of generics often resulting in substantial revenues
The CODAN Chemoprotect product range offers a safe and reliable protection of medical personnel during the handling of cytotoxic drugs The combined use of specially matched individual products considerably minimises the risk of contaminations in the regular handling of cytotoxic drugs as well as in case of accidents
GLOBAL MEDICINE DATABASE 66 full country medicine database 2 500 000 medicines Rx and OTC full information about each drug includingEx factory Wholesale and retail prices reimbursement information Active ingredients ATC levels administration routes strength trade names MA holder information real manufacturer information
Approval of medical devices in both the EU and the United States share some similarities The FDA assigns devices to 3 main regulatory classes low risk or Class I moderate risk or Class II and high risk or Class III the United States a Class I device requires merely a Premarket Notification without clinical trials whereas Class III devices require clinical trials and/or other
Drugs and Medical Devices and the Federal Office for Consumer Protection and Food Safety shall continue to apply in the version of the publication of 24 October 2003 Federal Law and Ordinance Gazette I P 2157 and as amended by Article 2 25 of the Law of 7 August 2013 Federal Law and Ordinance Gazette I P 3154 if the
The hefty price tag sweeping label and potential popularity of Biogen s newly approved Alzheimer s disease drug Aduhelm could create a heavy burden on the Medicare system and lead to drug price
DEHNbox TC B 180 The compact surge arrester provides reliable protection for information technology interfaces especially telecommunications connections such as VVDSL and G fast up to 1 G Bit/s with interference free data transmission Red/LineSurge protection
Defective product Incorrect potency Between 2018 and 2019 for example several drug companies recalled batches of the blood pressure medications valsartan irbesartan and losartan The medications contained trace amounts of the cancer causing chemicals N Nitrosodimethylamine NDMA and N nitrosodiethylamine NDEA
Russia presents a potentially lucrative market for medical device companies However the registration process can be a challenge Unlike most countries Russia still relies on in country testing and clinical data to approve medical devices even if the device is already sold in other major markets
Multicenter evaluation of a new closed system drug transfer device in reducing surface contamination by antineoplastic hazardous drugs Am J Health Syst Pharm 2018 75 Berdi F Powell MF Sanz C Gonzalez R and Massoomi F Assessing the efficiency of CSTDs for compounding
rus Comprehensive healthcare solutions We specialize in research development and production of pharmaceuticals laboratory equipment and medical devices We focus on the release of following medications Oncological Antiviral Autoimmune Orphan drugs Pulmonological
The most important factor that drives prescription drug prices higher in the United States than anywhere else in the world is the existence of government protected monopoly rights for
The drug company must follow the ASEAN common technical documents ACTD to be certified as compliant While seemingly straightforward the drug approval process is still not consistent across all ASEAN countries For example only about 5 of the drug industry in the Philippines is
Innovative 3 in 1 Protection Bullet List Kills fleas ticks and chewing lice Repels mosquitoes ticks and stable flies Protects for a full 30 days Single Paragraph
Food Drugs and Devices On May 11 and 12 2017 the China Food and Drug Administration CFDA published drafts of four proposed policies in the form of circulars or notices for public comment These Proposed Policies include significant reforms in the areas of the new drug and device approval process
Generics QbR Deficiencies Container closure attributes to ensure product quality Studies to identify necessary attributes including identity suitability safety protection compatibility and performance consistent with the QTPP Dosage form compatibility e g extractables leachables dye from labeling Compatibility with the sterilization procedure
An insight into regulatory pricing and reimbursement in South African Pharma Prepared in association with Fasken a leading global law firm this is an extract from The Pharma Legal Handbook South Africa available to purchase here for USD 99 1 What are the regulatory authorities with jurisdiction over drugs biologicals and medical devices in your country
Pharmaceutical Products Market Currently the size of the global pharmaceutical market is around 1 25 trillion U S dollars The range of pharma products varies from antibiotics which haven t
Prices of innovative drugs are mainly negotiated 4 The law reforming the pharmaceutical market Arzneimittelmarkt NeuordnungsgesetzAMNOG which took effect in January 2011 has kept the principle of free pricing at launch but imposes a systematic and formal assessment of the 6 │
The ASEAN region comprises 10 countries Malaysia Indonesia Thailand Philippines Singapore Brunei Vietnam Laos Cambodia and Myanmar All 10 countries are seeking economic development to improve competitiveness by eliminating trade barriers To help accomplish that many ASEAN regulatory guidelines are harmonized with ICH and EU guidelines
Orphan drugs would be given a price equivalent to 100 of the weighted average price of alternative treatments Pacific Bridge Medical s regulatory experts will take all factors into account and help your pharmaceutical or biotechnology company determine the most cost effective and time efficient way to obtain product approval in Korea
The term medical devices covers a vast range of equipment from simple tongue depressors to haemodialysis machines Like medicines and other health technologies they are essential for patient careat the bedside at the rural health clinic or at the large specialized hospital Medical devices also cost governments a substantial amount of
Canada s regulatory approach Drugs for rare diseases are authorized for sale in Canada under the Food and Drugs Act and Part C of the Food and Drug Regulations For more information on approved products refer to Drug and medical device highlights On this page
