Sep 30, 2019

PSUR submission summary in the United Kingdom (UK) about a possible no-deal Brexit

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Periodic Safety Update Reports (PSURs):-


A. PSURs submitted after exit day

a. MHRA will continue to accept EU version of PSURs
b. MHRA specific request for information needs to be included in specific annexure
c. MHRA has developed its own submission requirements and develop a list of UK reference dates, but until this happens the EU reference date (EURD) list should be followed and PSURs
d. PSUR submission dates after exit day should be submitted to the UK the same time as submission to the EU
e. The content and format of PSUR will be the same as the EU
f. It is expected the same PSUR will be submitted to the UK and EU
g. PSURs for actives/combinations not currently on the EURD list should be submitted to us according to the usual frequency
h. MHRA submission portal for PSUR will be ready for use before exit day
i. Submission to the portal via a delivery file with the PSUR as part of eCTD
j. A fee of £890 will be payable for the assessment of PSURs for actives/ combinations currently listed on the EURD (or future UK reference date list) but there will be a reduction to £445 for each PSUR where more than one PSUR is involved in the procedure
k. MHRA will publish the outcome of the PSUR assessment procedures
l. No further fees will be payable 

B. PSURs submitted before exit day

a. Where a PSUR has been submitted before exit day but the EU single-assessment procedure has not been concluded, we will assess the PSUR considering any relevant information, including any EU decision and may request further information, where appropriate, in order to conclude the assessment
b. Where the assessment has been concluded but the outcome not implemented on exit day, the MHRA will take the necessary steps to implement the outcome

Sep 22, 2019

Service Level Agreement (SLA) in Pharmacovigilance perspective

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Service Level Agreement (SLA) is generally mutual commitment between service provider and a client. In pharmacovigilance industry, pharmacovigilance service provider and pharmaceutical company (client) come together in agreement for various PV activities. This could be single PV activity or End to End PV activities on behalf of client.

Pharmacovigilance SLA is not differ from another domain like IT industry where it prevails since long. It contains following common components of any SLA like –

·         Nature and scope of work
o   Region specific (USA, EU or ROW) or Worldwide
o   Single PV activity (ICSR processing  or literature review, etc.) or End to End PV Activity (ICSR processing, Literature Review, Aggregate Reports (PSUR/ADCO/PADER), Risk Management Plan (RMP), Signal Detection, etc.)  
o   ICSR Processing - All type of ICSR processing (Regulatory, Literature, Spontaneous) or specialized ICSR processing i.e. clinical trial or litigation, processing and case submission timelines
o   Literature Review – Literature review from global databases like Embase, PubMed or local journal review or both local and global review, preparation and maintenance of search strings
o   Aggregate Reports – Aggregate Report schedule preparation and maintenance, Ad-hoc reports, Nature of report format (PSUR, PBRER or regional specific like ANVISA, CDSCO, COFEPRIS, etc.), timeline related to finalization of draft and submission
o   Risk Management Plan (RMP) – New RMP or Maintenance of RMP, preparation and management of additional risk minimization measures (ARMM) or additional pharmacovigilance activities like non-clinical studies, clinical trials or non-interventional studies.

·         Work management procedure
o   SOP to be followed (Client SOP or Service Provider SOP)
o   Work on inhouse client database or other commercially available database i.e. ARISg, ARGUS
o   Timelines to be followed for each activity

·         Quality parameters
o   Quality scoring for ICSR, Literature Review, Aggregate Reports, RMP and Signal detection activities

·         Compliance check
o   Regulatory compliance check
§  ICSR submission
§  Aggregate report submission
o   SLA compliance check
o   SDEA compliance

·         Business Continuity Plan (BCP)
o   Business Continuity Plan (BCP) details in case of natural disaster or man-made disaster

·         Audits & Inspection
o   Internal audit and frequency
o   Audit of each other
o   Audit of business partners and affiliates
o   Inspection handling plan, if any specific condition.
·         Penalty
o   Financial penalty in case of quality and quantity deviation from SLA

·         Termination clauses
o   Terms and conditions where termination of SLA to be impose like significant non-conformity in PV process
o   Critical regulatory observation due significant defect in service provider’s procedure

One should remember that SLA is a dynamic document and can be drafted and modified based upon the business need of pharmacovigilance service provider and pharmaceutical company (aka client).

Though dynamism present in SLA, each points of SLA should be thoroughly reviewed by each party who enters in to agreement.


Sep 14, 2019

Article 31 -EMA to review ranitidine medicines following detection of NDMA

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Under Article 31 of Directive 2001/80/EC, the review of ranitidine containing medicines was initiated at the request to the European Commission. This review will be carried out by the Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies. It is present in some foods and in water supplies but is not expected to cause harm when ingested in very low levels. In 2018, NDMA and similar compounds known as nitrosamines were found in several blood pressure medicines known as ‘sartans’ leading to recalls.

EMA is evaluating the data to assess whether patients using ranitidine are at any risk from NDMA and will provide information about this as soon as it is available.

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