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May 05, 2021

The Local Safety Responsible (LSR) role in the Arab GVP

As part of a pharmacovigilance (PV) system, Marketing Authorization Holders (MAHs) must appoint a Qualified Person responsible for Pharmacovigilance in the European Union (EU-QPPV). The EU-QPPV must reside and operate in one of the member states of the European Economic Area (EEA) and must permanently and continuously be at the disposal of the MAH. An appropriate backup procedure must be established to assure the QPPV function in case the EU-QPPV is temporarily unavailable.

The EU-QPPV is responsible to establish and maintain MAHs pharmacovigilance system and is personally responsible for overseeing all its relevant aspects. The EU-QPPV’s are the persons who influence the performance of the MAH’s quality system and the pharmacovigilance activities and promote, maintain and improve compliance with the legal requirements. In addition, the EU-QPPV is the single pharmacovigilance contact point for the EMA and the Competent Authorities in the EU on a 24/7 basis.

Supplementary to the EU-QPPV, the National Competent Authorities (NCA) of the EEA, may also require the nomination of a local contact person at the national level (i.e. the Local Person for Pharmacovigilance – LPPV). This person is expected to be knowledgeable in the specifics of the national PV system of the EEA member state, speak the national language(s) and facilitate communication with the NCA at the local level. We have recently summarized both the national LPPV requirements among EEA member states and have provided some strategic considerations on how these requirements can effectively be met:

More recently, the pharmaceutical industry has observed increasing requirements for QPPVs in regions outside the EU. Some good examples include the Arab League and the Eurasian Economic Union (EAEU). Both regions have their own set of Good Pharmacovigilance Practices (GVP) requirements and expectations for the QPPV. The EAEU GVP is essentially similar to the EU GVP and has a very similar setup of the EAEU-QPPV and LPPVs in the Eurasian Economic Union (EAEU) to those in the EEA. More interestingly, the Arab GVP, alongside the QPPV and LPPV/LCPPV roles, also introduced the term of the Local Safety Responsible (LSR). Within the Arab GVP, the LSR role is put in place and intended for the multinational MAHs who already have the global QPPV. For such MAHs, some Arab Countries may accept the LSR instead of the global QPPV. In this way, the Arab GVP establishes a distinction between the LSR role and the global QPPV function, whereas the QPPV has the global PV system responsibilities and the LSR bears responsibility for the local PV system in the Arab state. Of course, it must be noted, that NCAs of Arab countries may still require MAHs to nominate LPPV next to the QPPV/LSR, and there is also an option that the LSR may at the same fulfil the function of an LPPV. The LSR role established by the Arab GVP provides a good example, of how national competent authorities of different legislative regions can help MAHs integrate their global PV functions among different territories.

In a recent article, the European Federation of Pharmaceutical Industries and Associations (EFPIA) International Pharmacovigilance Group (IPVG) has also endorsed the distinction between QPPV and LSR roles, supporting the LSR role should be focused on local PV system oversight. To support the consistent establishment of the LSR role, the IPVG had also provided their position on the expected LSR profile, roles and responsibilities. According to IPVG, the LSR:

  • Oversees local pharmacovigilance processes and activities and has sufficient authority to influence the performance of the local PV system in order to comply with local applicable legislation;
  • Has adequate experience and training in locally required pharmacovigilance activities;
  • Is qualified to understand the safety profile of the MAH’s medicinal products;
  • Is not necessarily medically qualified but has access to a medically qualified person;
  • Is a resident of a country in a workable time zone (± 3 h) for the NCA, but not necessarily a resident of the country in which the NCA is located, to allow greater flexibility for MAHs which do not have a physical presence in a country and are providing medical supplies through distributors;
  • Speaks at least one of the national languages of the country concerned, but is not necessarily a national of the country;
  • Maybe an employee of a third party to whom responsibilities have been delegated in writing;
  • Is available as a contact person to the NCA during the usual office hours of the NCA;
  • Is the contact person for local pharmacovigilance inspections;
  • Has access to the global PV system description;
  • Has access to the local PV system description should one be required;
  • Maintains regular exchange with relevant company functions such as the QPPV responsible for the global PV system, e.g. via direct contact and/or minute sharing.

Conclusion

In countries, where it is possible to delegate most of the local PV activities and responsibilities to the regional or global organization of the MAH it may be sufficient to nominate only so-called Local Contact Persons for Pharmacovigilance (LPPV). The LPPVs fulfil the role of a contact person for any PV questions in the country and are continuously available for the NCA, and they do not need to fulfil the profile, role and responsibilities of an LSR. However, in the countries with their own set of GVP guidelines (for example the Arab GVP) or specific, stricter national requirements, the LSR role can serve as the middle part between the global QPPV and the LPPV functions.

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