Основными документами, генерируемыми при осуществлении фармаконадзора, являются:

  • План управления рисками (англ. Risk Management Plan – RMP),
  • Периодически обновляемый отчет по безопасности (англ. Periodic Safety Update Rep

The main documents generated in the course of pharmacovigilance are:

  • Risk Management Plan (RMP),
  • Periodic Safety Update Report (PSUR),
  • Addendum to the Clinical Overview (ACO).

The need to generate and to submit the Risk Management Plan (RMP) and Addendum to the Clinical Overview (ACO) in Ukraine arose after the new version of the Order of Ministry of Health of Ukraine (dated by August 26, 2005) No. 426 came into force (in wording of the MHU Order of July 23, 2015 No. 460) in October 2015, which has adapted the national requirements to the European ones:

Procedure

Before

Current

Registration

RMP

Re-registration

PSUR

RMP, ACO

Periodically

PSUR

PSUR

Renewal/creation as required

RMP

Owing to the entry into legal force of the amendments to the MHU order No. 460, in October 30, 2017 the transition period (2 years) will expire, during which RMP and ASO have been submitted if available, i.e. it was not a compulsory action provided for a guarantee letter presentation by the Applicant about the submission of mentioned documents to the Legislation specified deadline.

MHU order No. 426 (in wording of the Order No. 460):

”The risk management plan is obligatory for granting in 2 years from the date of Procedure implementation. Prior to the specified period, RMP is provided if available. RMP is not provided for the drug products originating from EU countries and re-registered in EU territory until June 2012, except for RMP is required by the results of the performed assessment of the benefit/risk ratio.

Addendum to the Clinical Overview is a mandatory one to be presented in 2 years from the date of Procedure implementation. Before the specified term ACO is provided if available, and it’s necessary to provide the latest Periodic Safety Update Report if ACO is absent. In case of ACO absence at the re-registration, Applicant must prepare and provide it for expertise to the Centre within 2 years after the Procedure implementation.”

Risk Management Plan (RMP) is a document containing a detailed description of the risk management system where the primary focus is made on the planning of activity for pharmacovigilance and risks minimization:

  • Identification of the important risks and missing information (safety specification);
  • Further risk study (pharmacovigilance plan);
  • Activity for the risks minimization (risk minimisation measures);
  • Estimation of the efficiency for the risk minimization measures.

Periodic Safety Update Report (PSUR) is the document where the primary focus is made on the analysis of available information of DP safety and efficacy and the assessment of benefit/risk ratio, intended for presentation periodically in Legislation specified terms:

  • analysis of information of DP safety (data on the adverse reactions and lack of DP efficacy);
  • revealing of the signals and their evaluation;
  • assessment of the benefit/risk ratio;
  • revealing and introduction of known risks at the drug product usage into the “basic safety profile”.

PSUR allows to summarize all the new data on the drug product safety obtained from various sources; to evaluate the experience of DP usage in populations that were not included in pre-registration clinical trials; to generalize the experience of drug product usage in different countries.

Addendum to the Clinical Overview (ACO) is the document where the primary focus is made on critical analysis of available information of DP safety and efficacy, and the current benefit/risk ratio at the time of DP re-registration based on the data contained in the PSUR (other DP safety and efficacy information obtained from the time of registration/last DP re-registration, including literature data monitoring), RMP and performed inspections. The need to provide ACO with re-registration occurred by the reason of non-coincidence of the last generated PSUR review period with review period at the re-registration.

PDF: Short comparison of Risk Management Plan (RMP), Periodic Safety Update Report (PSUR) and Addendum to the Clinical Overview (ACO)

The PV documents complement each other, and the information is duplicated in some parts of them. So, the key analytical part of PSUR and ACO is the benefit/risk ratio assessment.                                                                       

Cratia company offers the development (writing) of the pharmacovigilance documentation, namely:

  • development (writing) or completion of the Risk Management Plan – RMP,
  • development (writing) or completion of the Periodic Safety Update Report – PSUR,
  • development (writing) or completion of the Addendum to the Clinical Overview –ACO.

Our medical editors and staff of the pharmacovigilance department have the necessary knowledge, experience and skills for the qualified writing of mentioned documents.

We give the preliminary consultation in a pro-bono regime, please call us by phones +380(44)361 4828, 221 7129, or to write for e-m address info@cratia.ua, or come to the meeting directly i our office.