Regulatory Open Forum

Hi Garima, 

I was always reminded by local GCP inspectors from various European countries that national legislation always comes first. 

I would say no need for CAPA for providing DSUR on time per local requirements, thus being compliant with local authorities. 

However, if there was a safety reporting plan drafted between contractor/contractee which included global DSUR submission timeliness, and which did not state local requirements other than those described in ICH guidelines, this should be addressed formally as a process deviation. 

Local requirements should be known, discussed and captured in reporting plan for this exact situation to be avoided. If you expect DSUR submission to occur within timelines which are more strict than those defined in local regulatory framework, I think that should have been explicitly stated. 

There is this underlying challenge in communication pathways that often exists in contractor/contractee relations that might signal potential need to evaluate further this situation as well as reporting plans (if you don't have it in place, I strongly recommend drafting it as it will allow local differences to be captured and properly addressed), for occurances other than this might not end up with remaining compliant with local requirements.

I hope this helps and looking forward for others' comments on this topic.

Kind regards,

------------------------------
Vladimir Vujovic
Regulatory and Safety Manager
Belgrade
Serbia
------------------------------

Original Message:
Sent: 25-Apr-2019 14:54
From: Garima Sharma
Subject: DSUR submission guideline

Hi,

I have a question in reference to the ICH guideline on the submission of DSURs to the applicable countries. As per ICH, "The DSUR should be submitted to all concerned regulatory authorities no later than 60 calendar days after the DSUR data lock point." However some countries have a 70 or 90 days guideline and some don't have a time period of DSUR submission.

Now if we go by ICH guideline, if the submission is made after 60days, we consider them late and request a CAPA from the vendor doing the submission. However the vendor comes back saying that they are also not wrong as they are  following the local regulation of the country.

We are in a fix and would like your inputs on this topic. Any guidance is highly appreciated!

Thanks!

Original Message------

Hi Garima, 

I was always reminded by local GCP inspectors from various European countries that national legislation always comes first. 

I would say no need for CAPA for providing DSUR on time per local requirements, thus being compliant with local authorities. 

However, if there was a safety reporting plan drafted between contractor/contractee which included global DSUR submission timeliness, and which did not state local requirements other than those described in ICH guidelines, this should be addressed formally as a process deviation. 

Local requirements should be known, discussed and captured in reporting plan for this exact situation to be avoided. If you expect DSUR submission to occur within timelines which are more strict than those defined in local regulatory framework, I think that should have been explicitly stated. 

There is this underlying challenge in communication pathways that often exists in contractor/contractee relations that might signal potential need to evaluate further this situation as well as reporting plans (if you don't have it in place, I strongly recommend drafting it as it will allow local differences to be captured and properly addressed), for occurances other than this might not end up with remaining compliant with local requirements.

I hope this helps and looking forward for others' comments on this topic.

Kind regards,

------------------------------
Vladimir Vujovic
Regulatory and Safety Manager
Belgrade
Serbia
------------------------------

This message was posted by a user wishing to remain anonymous

​Hi ~

I would always follow the country guideline with regards to timelines, unless there is no country timeline in which case I would file according to the ICH recommendation (ie. no later than 60 days after DLP).

Regards
Original Message:
Sent: 25-Apr-2019 14:54
From: Garima Sharma
Subject: DSUR submission guideline

Hi,

I have a question in reference to the ICH guideline on the submission of DSURs to the applicable countries. As per ICH, "The DSUR should be submitted to all concerned regulatory authorities no later than 60 calendar days after the DSUR data lock point." However some countries have a 70 or 90 days guideline and some don't have a time period of DSUR submission.

Now if we go by ICH guideline, if the submission is made after 60days, we consider them late and request a CAPA from the vendor doing the submission. However the vendor comes back saying that they are also not wrong as they are  following the local regulation of the country.

We are in a fix and would like your inputs on this topic. Any guidance is highly appreciated!

Thanks!

Original Message------

This message was posted by a user wishing to remain anonymous

​Hi ~

I would always follow the country guideline with regards to timelines, unless there is no country timeline in which case I would file according to the ICH recommendation (ie. no later than 60 days after DLP).

Regards

HI Garima,

I think, you need to follow country specific timelines over ICH. Mostly requirements are different in country to country and ICH is offering standard timelines/requirements.

Regards
Hrishikesh

------------------------------
Hrishikesh Dhongade MS
Manager, Reg Ops
Hyderabad
India
------------------------------

Original Message:
Sent: 25-Apr-2019 14:54
From: Garima Sharma
Subject: DSUR submission guideline

Hi,

I have a question in reference to the ICH guideline on the submission of DSURs to the applicable countries. As per ICH, "The DSUR should be submitted to all concerned regulatory authorities no later than 60 calendar days after the DSUR data lock point." However some countries have a 70 or 90 days guideline and some don't have a time period of DSUR submission.

Now if we go by ICH guideline, if the submission is made after 60days, we consider them late and request a CAPA from the vendor doing the submission. However the vendor comes back saying that they are also not wrong as they are  following the local regulation of the country.

We are in a fix and would like your inputs on this topic. Any guidance is highly appreciated!

Thanks!

Original Message------

HI Garima,

I think, you need to follow country specific timelines over ICH. Mostly requirements are different in country to country and ICH is offering standard timelines/requirements.

Regards
Hrishikesh

------------------------------
Hrishikesh Dhongade MS
Manager, Reg Ops
Hyderabad
India
------------------------------

My only suggestion would be to ask for their procedure that governs DSUR submissions and then review to see if this is allowed per their procedure. If it is  and following their procedure, then not sure how you can ask for a CAPA as followed their procedure. Subsequently, if you not like their procedure , you would need to contractually address.

------------------------------
Robert Blanks RAC
VP, Regulatory Affairs and Quality Assurance
[Ardelyx]
Auburndale MA
United States
------------------------------

Original Message:
Sent: 25-Apr-2019 14:54
From: Garima Sharma
Subject: DSUR submission guideline

Hi,

I have a question in reference to the ICH guideline on the submission of DSURs to the applicable countries. As per ICH, "The DSUR should be submitted to all concerned regulatory authorities no later than 60 calendar days after the DSUR data lock point." However some countries have a 70 or 90 days guideline and some don't have a time period of DSUR submission.

Now if we go by ICH guideline, if the submission is made after 60days, we consider them late and request a CAPA from the vendor doing the submission. However the vendor comes back saying that they are also not wrong as they are  following the local regulation of the country.

We are in a fix and would like your inputs on this topic. Any guidance is highly appreciated!

Thanks!

Original Message------

My only suggestion would be to ask for their procedure that governs DSUR submissions and then review to see if this is allowed per their procedure. If it is  and following their procedure, then not sure how you can ask for a CAPA as followed their procedure. Subsequently, if you not like their procedure , you would need to contractually address.

------------------------------
Robert Blanks RAC
VP, Regulatory Affairs and Quality Assurance
[Ardelyx]
Auburndale MA
United States
------------------------------