YOU ARE THE REASON
Claire Keane
#extradirty
Cosmic Funnies
shark vs the universe
sheepfilms
RMH
titsay
Origami Around
let's talk about Bridgerton tea, my ask is open
Cosimo Galluzzi
dirt enthusiast
will byers stan first human second
Jules of Nature
"I'm Dorothy Gale from Kansas"
art blog(derogatory)
we're not kids anymore.
@theartofmadeline
PUT YOUR BEARD IN MY MOUTH
blake kathryn
seen from Netherlands
seen from Malaysia
seen from Germany
seen from Romania
seen from Singapore
seen from Türkiye
seen from Singapore
seen from United States
seen from Malaysia
seen from Türkiye
seen from United Kingdom
seen from Türkiye
seen from United States
seen from United Kingdom
seen from Argentina
seen from Canada
seen from Malaysia
seen from Thailand
seen from United States
seen from Brazil
@luigiderosa
EU, Japan and US: a single development programme for new antibiotics
Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), met in Tokyo last month to plot out an approach that would allow drugmakers to conduct a single development plan for new antibiotics.
Representatives of the three regulatory agencies discussed the progress made in their collaboration at a…
View On WordPress
EDQM publishes the final report of its Pharmaceutical Care Quality Indicators Project
EDQM publishes the final report of its Pharmaceutical Care Quality Indicators Project
The EDQM has just published the final report of its Pharmaceutical Care Quality Indicators Project.
The report presents the results of the multinational validation study aimed at validating 4 basic sets of indicators to assess the quality of pharmaceutical care in Europe. It also contains the data collection forms that were developed and used in the above validation study. This report will…
View On WordPress
Eight European drug regulatory authorities will be able to conduct FDA GMP inpsections
Eight European drug regulatory authorities will be able to conduct FDA GMP inpsections
The U.S. Food and Drug Administration will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.
This achievement marks an important milestone to…
View On WordPress
You could finally use CEP in Brazil
You could finally use CEP in Brazil
The European Directorate for the Quality of Medicines & HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, have signed a Memorandum of Understanding which lays the foundation for ANVISA to consider the use of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) for their evaluation of marketing authorisation applications (MAAs) for medicinal…
View On WordPress
Similarity by Design: comparative Assessment of Quality Attributes - EMA Reflection Paper
Similarity by Design: comparative Assessment of Quality Attributes – EMA Reflection Paper
The European Medicines Agency (EMA) recently released a draft Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development. The deadline for comments is March 31, 2018. A European Medicines Agency’s public workshop at the end of the 12-month public consultation phase will provide the opportunity for further discussion of the content of this…
View On WordPress
10.000 take part to the world-first trial for universal flu vaccine
10.000 take part to the world-first trial for universal flu vaccine
More than 10,000 people aged 65 and over will be asked to take part in a study supported by the National Institute for Health Research (NIHR) and delivered by the University of Oxford in Berkshire and Oxfordshire. The recruitment target is 500. Researchers believe the vaccine could have a major impact on the worldwide fight against the virus, which affects about a billion people worldwide a year…
View On WordPress
Advancement of Emerging Technology: FDA Guidance
Advancement of Emerging Technology: FDA Guidance
The US Food and Drug Administration (FDA) on 29 September finalized its guidance entitled “Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization” detailing how drugmakers can participate in the agency’s program to advance the use of emerging manufacturing technologies, such as continuous manufacturing or 3D printing.
This guidance finalizes the draft…
View On WordPress
FDA: 'Broken' Clinical Trials System and Real World Evidence
FDA: ‘Broken’ Clinical Trials System and Real World Evidence
In a presentation at a workshop at the National Academies of Sciences, Engineering and Medicine, FDA Center for Drug Evaluation and Research’s Janet Woodcock said the current clinical trials system is “broken” and there needs to be new ways to collect and utilize patient data.
She mentioned master protocols (studies that assess multiple therapies in a single disease or a single treatment in…
View On WordPress
API starting materials - New Q&A document for ICH Q11
API starting materials – New Q&A document for ICH Q11
The selection of a starting material for the synthesis of an active substance and its justification is often one of the most crucial steps in the approval process. Assessors at regulatory agencies of the EU member states have to evaluate whether the data provided sufficiently justify the selection. The criteria for this are outlined in the 2012 ICH Q11guideline – however, not in a sufficiently…
View On WordPress
Process Validation never ends
Process Validation never ends
It was 2011 when FDA published their Guidance for Industry: Process Validation: General Principles and Practices. This document radically changed FDA interpretation of process validation. According to the guidelines validation means “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of…
View On WordPress
United Kingdom is now a "third country": government position paper
United Kingdom is now a “third country”: government position paper
In May 2017 the EU Commission and EMA made a clear statement: after 30 March 2019 the Unit Kingdom will become a ‘third country’.
In a common Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use, the Commission and the Agency get the point strait that “all Union primary and secondary law ceases to apply to the United Kingdom from 30…
View On WordPress
New EU Regulations on Medical Devices: how to comply?
New EU Regulations on Medical Devices: how to comply?
On 5 April 2017, 2 new Regulations on medical devices were adopted. These replace the existing Directives.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Regulation (EU) 2017/746of the…
View On WordPress
Commercially Confidential Information can now be shared between EMA and FDA
Commercially Confidential Information can now be shared between EMA and FDA
New commitment allows FDA to share full inspection reports with European Commission and EMA
The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the US regulator to share non-public and [su_tooltip style=”bootstrap” content=”Information whose publication might…
View On WordPress
The most cited GMP inspection deficiencies
The most cited GMP inspection deficiencies
Every year the MHRA publishes the inspectorate deficiency trend data with the hope that industry will perform their own assessment against the deficiency findings, as part of self-inspection and continuous improvement.
In 2016, compared to 2015, the MHRA increased the number of inspections from 303 to 324, with overseas inspections increasing from 79 to 82. The deficiencies are categorized into…
View On WordPress
FDA Draft Guidance to Further Secure Drug Supply Chain
FDA Draft Guidance to Further Secure Drug Supply Chain
The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013.
The Drug Supply Chain Security Act (DSCSA) outlines requirements for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics…
View On WordPress
'Accelerated approval' drugs: Characterization of preapproval and confirmatory clinical trials
‘Accelerated approval’ drugs: Characterization of preapproval and confirmatory clinical trials
When an investigational prescription drug shows promise for treating a serious illness or filling an unmet medical need, the Food and Drug Administration (FDA) has special programs available to expedite its clinical testing and approval. One is the “Accelerated Approval” pathway, in which the FDA will accept weaker-than-usual evidence of the drug’s efficacy from its pre-clinical trials. In…
View On WordPress
Starting Material for API manufacturing: EMA expectations
Starting Material for API manufacturing: EMA expectations
The description of manufacturing process is an integral part of an approval dossier’s quality documentation for an API. According to the current regulation the applicant has to define his starting material and justify his selection.
However disagreements between applicants and quality assessors on the suitability of proposed starting materials have become more frequent in recent times. This…
View On WordPress