A brief summary from MHRA Pharmacovigilance Inspection Metrics Report: April-2018 - March 2019

During the period 01 April 2018 to 31 March 2019, the MHRA’s Good Pharmacovigilance Practice (GPvP) inspectorate conducted 18 inspections of marketing authorisation holders (MAHs). The MHRA has recently published their latest Pharmacovigilance Inspection Metrics for the period from April 2018 to March 2019. 

Since 2009, Pharmacovigilance Inspection Metrics is annually published by MHRA. As per the Pharmacovigilance Inspection Metrics Report, the purpose of these inspections was to determine compliance with EU and respective national pharmacovigilance guidelines and regulations. 

During the period 01 April 2018 to 31 March 2019, the MHRA’s Good Pharmacovigilance Practice (GPvP) inspectorate conducted 18 inspections of marketing authorisation holders (MAHs).

Inspection Summary:

    

Summary of findings:

A total of four critical, 78 major and 38 minor findings were identified during this period.

How findings were categorized –

1.   Critical findings:
 

A.     Risk management: implementation of updated patient information leaflets

B.     Risk management: additional risk minimisation measures

C.     Quality management system: management of known non-compliance in the

D.     pharmacovigilance system, mechanisms for compliance management, written procedures

E.     Provision of information for inspections

 

2.   Major findings

A.     Risk management

B.     Ongoing safety evaluation

C.     Provision of information for supervision by NCAs including via inspection

D.     Quality management system

E.     Management of adverse drug reactions

F.      Collection and collation of adverse drug reactions

G.     Clinical trials pharmacovigilance

H.    Other

The largest the proportion of major findings was composed of non-compliances in relation to risk management, ongoing safety evaluation and provision of information for supervision by NCAs including via inspection.

3. Minor findings

A.     Collection and collation of adverse drug reactions

B.     Collection and collation of adverse drug reactions

C.     Ongoing safety evaluation

D.     Risk management

E.     Management of adverse drug reactions

F.      Clinical trials pharmacovigilance

G.     Provision of information for supervision by NCAs and inspection

The largest the proportion of minor findings was composed of non-compliances in relation to the collection and collation of adverse drug reactions, followed by findings in relation to the quality management system and ongoing safety evaluation.

Specific area of concern -

               A.     Risk management

 There were 24 findings were identified from the risk management plan which was reported from 13 out of 18 inspections.  

   

        B.     Ongoing safety evaluation

There were 22 findings were identified from the risk management plan which was reported from 14 out of 18 inspections. 

 

    C.     Biological medicinal products 

   Major findings were reported for signal management activities as the MAH had not incorporated the specific requirements for biologicals as described in GVP Product- or Population Specific Considerations II: Biological medicinal products (GVP PII) into the signal management activities for these products.

Failures to evaluate signals for biologicals in the context of batch-specific exposure data to identify any changes in product safety and quality over time.

SmPC and PIL of the biological medicine did not include a prominent statement that the name and batch number of the administered product should be clearly recorded in the patient file. Such wording is important to improve the traceability of biological medicines.

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