No chance against RMS? [Regulatives / Guidelines]
Dear Dan,
Under the first point I think I would add that you have not (have you?) received questions for module 3 and specifications; thus, the potential variability from the studies reflects -at least in part- the natural variation within the specifications that the M3 assessor has accepted.
You are right, a referral will not be triggered if the RMS disagrees. This is a new thing and there is very little you can do. If the RMS enforces a principle that has never been defined in a guideline document and which is not in line with contemporary equivalence thinking then honestly I think this would be a case for the European Generics Association. This is a slow process and not one that can be expected to work here and now.
Having said that, I am pretty sure regulators from BfArM are seeing this thread and giving it some consideration. That would potentially be in your favour.
I actually still believe your product is alive.
Under the first point I think I would add that you have not (have you?) received questions for module 3 and specifications; thus, the potential variability from the studies reflects -at least in part- the natural variation within the specifications that the M3 assessor has accepted.
You are right, a referral will not be triggered if the RMS disagrees. This is a new thing and there is very little you can do. If the RMS enforces a principle that has never been defined in a guideline document and which is not in line with contemporary equivalence thinking then honestly I think this would be a case for the European Generics Association. This is a slow process and not one that can be expected to work here and now.
Having said that, I am pretty sure regulators from BfArM are seeing this thread and giving it some consideration. That would potentially be in your favour.
I actually still believe your product is alive.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- inter-batch variability? Dr_Dan 2010-08-04 10:29
- inter-batch variability? Pavidus 2010-08-04 11:57
- inter-batch variability? d_labes 2010-08-04 13:58
- inter-batch variability? ElMaestro 2010-08-04 17:09
- Between study variability common for HVDs Helmut 2010-08-04 19:45
- Between study variability common for HVDs ElMaestro 2010-08-04 21:01
- Representative batches? Helmut 2010-08-04 23:42
- Representative batches? ElMaestro 2010-08-05 08:40
- Representative batches? Helmut 2010-08-05 12:30
- Representative batches? Dr_Dan 2010-08-05 08:58
- Representative batches? Helmut 2010-08-05 12:45
- Confidence intervals vs. point estimators Dr_Dan 2010-08-06 09:55
- Confidence intervals vs. point estimators ElMaestro 2010-08-06 12:34
- Confidence intervals vs. point estimates Helmut 2010-08-06 13:20
- Confidence intervals vs. point estimators Dr_Dan 2010-08-06 14:44
- Confidence intervals vs. point estimators ElMaestro 2010-08-06 15:01
- meta analysis? martin 2010-08-06 17:25
- meta analysis? ElMaestro 2010-08-06 17:57
- meta analysis? Helmut 2010-08-06 18:31
- meta analysis? Ohlbe 2010-08-06 23:21
- No chance against RMS? Dr_Dan 2010-08-10 12:27
- No chance against RMS?ElMaestro 2010-08-10 16:26
- No chance against RMS? Dr_Dan 2010-08-10 12:27
- meta analysis? ElMaestro 2010-08-06 17:57
- meta analysis? martin 2010-08-06 17:25
- Confidence intervals vs. point estimators ElMaestro 2010-08-06 15:01
- Confidence intervals vs. point estimators ElMaestro 2010-08-06 12:34
- Confidence intervals vs. point estimators Dr_Dan 2010-08-06 09:55
- Representative batches? Helmut 2010-08-05 12:45
- Representative batches? ElMaestro 2010-08-05 08:40
- Representative batches? Helmut 2010-08-04 23:42
- Between study variability common for HVDs ElMaestro 2010-08-04 21:01
- Batch-to-Batch Pharmacokinetic Variability kumarnaidu 2016-07-20 07:16
- tlast (Common) Helmut 2016-07-20 10:48
- tlast (Common) nobody 2019-02-21 15:20
- tlast (Common) ElMaestro 2019-02-21 16:32
- tlast (Common) nobody 2019-02-21 17:02
- tlast (Common) ElMaestro 2019-02-21 18:02
- tlast (Common) nobody 2019-02-21 18:17
- tlast (Common) ElMaestro 2019-02-21 18:02
- tlast (Common) nobody 2019-02-21 17:02
- tlast (Common) ElMaestro 2019-02-21 16:32
- tlast (Common) nobody 2019-02-21 15:20
- tlast (Common) Helmut 2016-07-20 10:48
- Between study variability common for HVDs Helmut 2010-08-04 19:45