Drug Regulators, EMEA (EMA), Publish Draft Guidance on the Investigation of Bioequivalence.
Full text Here
Organisations that commented on the draft Guideline as released for consultation
1 EFPIA
2 European Generic medicines Association (EGA)
3 EUFEPS Network on BABP
4 FIP Special Interest Group on BCS and Biowaiver
5 BPI-German Pharmaceutical Industry Association
6 The Association of the European Self Medication Industry (AESGP)
7 European Federation of Statisticians in the Pharmaceutical Industry
8 European Quality Assurance Confederation
9 International Association for Pharmaceutical Technology
10 BEBAC-Consultancy Services for bioequivalence and Bioavailability Studies
11 CIPLA LTD. INDIA
12 Pharmascience Inc. Montreal, Canada
13 Anapharm
14 Lupin Bioresearch Center
15 MANEESH PHARMACEUTICALS, LTD
16 MDS PHARMA SERVICES
17 POLFA TARCHOMIN S.A
18 PHAST GmbH
19 Jenson Pharmaceutical Services Ltd
20 Douglas Pharmaceuticals Ltd
21 Ratiopharm GmbH
22 Ranbaxy
23 Orion Corp. Orion Pharma
24 Gilead Sciences International Ltd
25 CEPHA s.r.o.
26 H.L. Lundbeck A/S
27 Combino-pharm
28 Bayer Schering Pharma AG/Clinical Pharmacology and Global Pharmacometrics
29 Quinta Analytica-s.r.o.
30 Hexal AG
31 Synthon BV
32 UCB Pharma S.A.
33 Merck Sharp & Dohme (Europe) Inc
34 ACC GmbH, Analytical Clinical Concepts
35 Slovak National Accreditation Service
36 Good Laboratory Practice Monitoring Authority
37 Norwegian Accreditation
38 Eye- Care Industries European Economic interest grouping
39 Dr. Nasir Idkaidek
40 Patrick Nicolas
41 Atholl Johnston
42 Laszlo Endrenyi
43 Aldo Rescigno
44 Carla M Catsmella
45 Salvador Fudio
46 Dr. Kamal K. Midha and Dr. Gordon McKay
47 Swissmedic
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
BBC Health News
Drug Regulators, EMEA (EMA), Publish Comments Draft Guidance on the Investigation of Bioequivalence
Drug Regulators, EMEA (EMA), Publish Draft Guidance on the Investigation of Bioequivalence.
Full text Here
Organisations that commented on the draft Guideline as released for consultation
1 EFPIA
2 European Generic medicines Association (EGA)
3 EUFEPS Network on BABP
4 FIP Special Interest Group on BCS and Biowaiver
5 BPI-German Pharmaceutical Industry Association
6 The Association of the European Self Medication Industry (AESGP)
7 European Federation of Statisticians in the Pharmaceutical Industry
8 European Quality Assurance Confederation
9 International Association for Pharmaceutical Technology
10 BEBAC-Consultancy Services for bioequivalence and Bioavailability Studies
11 CIPLA LTD. INDIA
12 Pharmascience Inc. Montreal, Canada
13 Anapharm
14 Lupin Bioresearch Center
15 MANEESH PHARMACEUTICALS, LTD
16 MDS PHARMA SERVICES
17 POLFA TARCHOMIN S.A
18 PHAST GmbH
19 Jenson Pharmaceutical Services Ltd
20 Douglas Pharmaceuticals Ltd
21 Ratiopharm GmbH
22 Ranbaxy
23 Orion Corp. Orion Pharma
24 Gilead Sciences International Ltd
25 CEPHA s.r.o.
26 H.L. Lundbeck A/S
27 Combino-pharm
28 Bayer Schering Pharma AG/Clinical Pharmacology and Global Pharmacometrics
29 Quinta Analytica-s.r.o.
30 Hexal AG
31 Synthon BV
32 UCB Pharma S.A.
33 Merck Sharp & Dohme (Europe) Inc
34 ACC GmbH, Analytical Clinical Concepts
35 Slovak National Accreditation Service
36 Good Laboratory Practice Monitoring Authority
37 Norwegian Accreditation
38 Eye- Care Industries European Economic interest grouping
39 Dr. Nasir Idkaidek
40 Patrick Nicolas
41 Atholl Johnston
42 Laszlo Endrenyi
43 Aldo Rescigno
44 Carla M Catsmella
45 Salvador Fudio
46 Dr. Kamal K. Midha and Dr. Gordon McKay
47 Swissmedic
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulattions, rules and initiatives each month, and summarise them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!
Fill Out the Short Form Below…
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”