STANDARD Written By: COPY TO;

OPERATING Dr. E. Muigai

PROCEDURE NO: QA/RA Pharmacist
QA/***/X ____________________
Edition No.: X
Approved By:
PROCEDURE FOR Mr. ___________
Supersedes Edition: IX
REGULATORY Dr. _______
INTELLIGENCE Effective Date:
Dr. _________
Authorised By: Review Date:
Mr. N. Shrivastava
Q.A. Manager __________________

1.0 PURPOSE:
The scope describes the process to screen and assess new or updated Pharmacovigilance
(PV), Clinical, and Regulatory Affairs (RA) regulatory policy documents on a regular basis
for potential impact on company procedures, the documentation of the impact analysis, and
the monitoring and completion of required implementation activities by Elys Chemical
Industries.
RESPONSIBILITY:
The Qualified Person for Pharmacovigilance/Deputy QPPV shall be responsible for
Regulatory Intelligence activities that include four essential components: monitoring,
analysis, reporting, and communications.

No change in this SOP may be made without authority.

Introduction:
Regulatory Intelligence is the act of gathering and analysing publicly available regulatory
information. This includes communicating the implications of that information, and
monitoring the current regulatory environment for opportunities to shape future regulations,
guidance, policy, and legislation.
Regulatory Intelligence helps Elys Chemical Industries anticipate and manage global
regulatory developments in a single solution, removing the burden of having to manually
track multiple sources of regulatory information from Primary research that covers data
across country updates, regulatory updates, parliamentary coverage, trade association
coverage, authority, ministry coverage, key opinion leaders and influencers.
Secondary research that encompasses data about country/product, regulatory landscape,
clinical updates, and intelligence, news, and newsletters.

Page 1 of 5
STANDARD Written By: COPY TO;
OPERATING Dr. E. Muigai
PROCEDURE NO: QA/RA Pharmacist
QA/***/X ____________________
Edition No.: X
Approved By:
PROCEDURE FOR Mr. ___________
Supersedes Edition: IX
REGULATORY Dr. _______
INTELLIGENCE Effective Date:
Dr. _________
Authorised By: Review Date:
Mr. N. Shrivastava
Q.A. Manager __________________

Regulatory Intelligence does not include-;

 Competitive intelligence (sometimes done by the regulatory department, more often
done by the marketing department)
 Proprietary information
 Sales or marketing information
 Drug pricing or insurance information
 Reimbursement issues.
Areas of interest that are screened in Regulatory Intelligence include many aspects of
pharmacovigilance. They may include the need a range of requirements, such as:
 Individual Case Safety Reports (ICSR)
 Periodic Safety Update Reports (PSUR)
 Risk Management Plans (RMP)
 Pharmacovigilance System Master File (PSMF)
Sources of regulatory information-;
 Pharmaceutical industry groups e.g. Kenya Association of Pharmaceutical Industry,
Pharmaceutical Society of Kenya, Kenya Association of Pharmaceutical Manufacturers.
 Medical Literature and publications.
 Events data
 Insurance companies
 Health Authority websites

Page 2 of 5
STANDARD Written By: COPY TO;
OPERATING Dr. E. Muigai
PROCEDURE NO: QA/RA Pharmacist
QA/***/X ____________________
Edition No.: X
Approved By:
PROCEDURE FOR Mr. ___________
Supersedes Edition: IX
REGULATORY Dr. _______
INTELLIGENCE Effective Date:
Dr. _________
Authorised By: Review Date:
Mr. N. Shrivastava
Q.A. Manager __________________

2.0 PROCEDURE:
2.1.1 The QPPV/Deputy QPPV shall on the first five days of every month carry out regulatory
intelligence activities by monitoring the health authority websites as per the regulatory
intelligence data tracking sheet. This shall include to analyse each country unique
requirements. Typical steps to achieve regulatory compliance include the following:
2.1.1.1 Identify applicable regulations. Determine which laws and compliance
regulations apply to the Elys Chemical Industry and operations. These
include National, State and Municipal rules.
2.1.1.2 Determine requirements. Identify the requirements in each regulation
that are relevant to Elys chemical industries, and consider plans on how
to implement these mandates.
2.1.1.3 Document compliance processes. Clearly document compliance
processes, with specific instructions for each role involved in
maintaining compliance. This information will be useful during
regulatory audits.
2.1.1.4 Monitor changes, and determine whether they apply. Compliance
requirements are updated constantly. Changes to be monitored to
determine if they are relevant to Elys chemical industry. If they are, the
QPPV/Deputy QPPV shall implement updated procedures, and train the
appropriate staff on these updates.
2.1.1.5 A screen shot of the analysed health authority website shall be
collected, printed and stored in the archives as part of proof that
regulatory intelligence was conducted.

Page 3 of 5
STANDARD Written By: COPY TO;
OPERATING Dr. E. Muigai
PROCEDURE NO: QA/RA Pharmacist
QA/***/X ____________________
Edition No.: X
Approved By:
PROCEDURE FOR Mr. ___________
Supersedes Edition: IX
REGULATORY Dr. _______
INTELLIGENCE Effective Date:
Dr. _________
Authorised By: Review Date:
Mr. N. Shrivastava
Q.A. Manager __________________

2.1.2 Communication
2.1.3 The QPPV/Deputy QPPV shall be responsible for the communication of new/updated
legislation/guidelines detected to management team on a monthly basis as per annexure 1
regulatory intelligence data collection form for update of new legislation/guidelines.
2.1.4 For regulatory reporting purposes the clock starts (day zero) on the day when the journal is
received/extracted from online sources by Elys Chemical Industries. The ICSR timelines for
Serious ADR are 15 calendar day. Non-serious case shall be submitted alongside the
scheduled PSUR for a particular product.

3.0 ANNEXURE:

ANNEXURE
TITLE OF THE ANNEXURES FORM NO.
NO.
Annexure I
Annexure II Databases and Product List Reconciliation form.

Page 4 of 5
STANDARD Written By: COPY TO;
OPERATING Dr. E. Muigai
PROCEDURE NO: QA/RA Pharmacist
QA/***/X ____________________
Edition No.: X
Approved By:
PROCEDURE FOR Mr. ___________
Supersedes Edition: IX
REGULATORY Dr. _______
INTELLIGENCE Effective Date:
Dr. _________
Authorised By: Review Date:
Mr. N. Shrivastava
Q.A. Manager __________________

4.0 ABBREVIATIONS:

SR.NO. ABBREVIATIONS FULL FORM

01 QPPV Qualified Person for Pharmacovigilance

5.0 REVISION HISTORY:

EDITION EFFECTIVE
REVISION SUMMARY
NO. DATES

I Need for an SOP was realised.

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