EPVC newsletter sixty three-April 2015

1. Part I of II
EPVC Newsletter
Egyptian
Pharmaceutical
Vigilance Center
(EPVC)
Pharmacovigilance
Department
Inside this issue:
EPVC regional
center of Cairo-
QPPV training
workshop in El-
Menoufia
1
EPVC – PBRER
training workshop
in Cairo
1
“Batches” Recall of
some pharmaceuti-
cal products from
the Egyptian mar-
ket
1
Recall from the
Egyptian market
due to counterfeit
2
Post-Marketing
Surveillance for
Sofosbuvir
4
Volume 6, Issue 4April 2015
EPVC – PBRER training workshop in Cairo
The Egyptian Pharmaceutical Vigilance center (EPVC) has organized a
training workshop on the New Arab Guidelines for PBRER (Periodic Bene-
fit Risk Evaluation Report) which was held in the NTI (National Training
Institute) at Cairo.
50 Marketing Authorization Holders from all Arab countries has attended
this training from 22nd
to 24th
of March 2015.
“Batches” Recall of some pharmaceutical products
from the Egyptian market
EPVC regional center of Cairo - QPPV training
workshop in El- Menoufia
On 15 March 2015, the regional center
of Cairo has organized “Hospital
QPPVs training workshop” which was
held in The National Liver Institute.
100 physicians and pharmacists from
different hospitals and health care insti-
tutions in El-Menoufia were highly se-
lected by their managers to act as
QPPV representatives and contact
points at their work places.
The “Drug Factories Inspection Department” at the Central Administration
of Pharmaceutical Affairs (CAPA) has decided to recall specific batches of the
following Pharmaceutical products:

2. Volume 6, Issue 4Page 2 Part I EPVC
Recall from the Egyptian market due to counterfeit
The department of Pharmacies & Warehouse Inspection at CAPA has decided to recall the imitated
packages of Kefadim 500mg & 1gm vial.
The original packages are manufactured by SIGMATEC for EPCI.
Pharmaceutical Product MAH Batch num-
bers
Reason
Sodium Valproate Oral Solution Delta Phar-
ma
41507 Non conformity of physical
properties
Erythrin Granules for 80 ml sus-
pension
Misr co.
for Phar-
maceutical
Industries
155024
154024
Non conformity of physical
properties
Tamsul 0.4mg 30 Capsules Amoun 140389 Non conformity of physical
properties
E-Moxclav 228.5mg EIPICO 1400457 Non conformity of physical
properties
Beco Tablets Misr co.
for Phar-
maceutical
Industries
154103
120074
Non conformity of chemical
analysis
Lidocaine HCL vial UGP
(United
Group
Pharma-
ceuticals)
30045dk
26275dk
26270dk
25265dk
27345dk
Technical committee decision
on 19/02/2015
Precedex solution for I.V. infu-
sion
UGP
(United
Group
Pharma-
ceuticals)
27322dk
27326dk
28078dk
27326dk
Technical committee decision
on 19/02/2015
This decision was circulated to the Manufacturers,
Marketing Authorization Holders (MAH) and Distributers
for these products to discontinue distribution of stocks and
recall the amount sold of these batches ONLY from
pharmacies.
Necessary measures would be taken against the violators.

3. Volume 6, Issue 4Page 3 Part I EPVC
Kefadim 500mg Vial
Kefadim 1g Vial
Original packages Fake Packages
The outer Package:
 “ECPI” word is written in light grey color
inside a light green rectangle.
 The printing house name “El-Mohandes
Press” is written down on the package.
The outer Package:
 “ECPI” word is written in dark grey color
inside a dark green rectangle.
 The printing house name is not written
down on the package.
The vial:
 The vial cap is blue.
 Powder amount is less.
 “ECPI” word is written on the label in-
side a light green rectangle.
The vial:
 The vial cap is pale blue.
 Powder amount is more.
 “ECPI” word is written on the label in-
side a dark green rectangle.
Original packages Fake Packages
The outer Package:
 “ECPI” word is written in light grey color
inside a light green rectangle.
 The printing house name “El-Mohandes
Press” is written down on the package.
The outer Package:
 “ECPI” word is written in dark grey color
inside a dark green rectangle.
 The printing house name is not written
down on the package.
The vial:
 The vial cap is dark red
 Powder amount is less
 “ECPI” word is written on the label in-
side a light green rectangle.
The vial:
 The vial cap is light red
 Powder amount is more
 “ECPI” word is written on the label in-
side a dark green rectangle.
These counterfeited packages can be differentiated from the fake ones as follows:

4. Volume 6, Issue 4Page 4 Part I EPVC
Sofosbuvir is a nucleotide analog used in combi-
nation with other drugs for the treatment
of hepatitis C virus (HCV) infection. It has been
marketed since 2013. Compared to previous treat-
ments, sofosbuvir-based regimens provide a high-
er cure rate, fewer side effects, and a two- to four-
fold reduced duration of therapy. Sofosbuvir al-
lows most patients to be treated successfully with-
out the use of peginterferon, an injectable drug
with severe side effects that is a key component of
older drug combinations for the treatment of
HCV.
Sofosbuvir inhibits the RNA polymerase that the
hepatitis C virus uses to replicate its RNA. In
2013, the FDA approved sofosbuvir in combina-
tion with ribavirin (RBV) for oral dual therapy
of HCV genotypes 2 and 3, and for triple therapy
with injected pegylated interferon (pegIFN) and
RBV for treatment-naive patients with HCV geno-
types 1 and 4.
On 27/11/2014
The Technical Committee at CAPA has approved
EPVC recommendations that all MAH for Sofos-
buvir are obliged to establish a Pharmacovigilance
system and to submit all the Pharmacovigilance
documents as a condition for its registration pro-
cess.
On 4/12/2014
EPVC announced the Pharmacovigilance require-
ments for the national companies who intended to
register Sofosbuvir molecule (similarly as the in-
novator):
A. Adherence to the treatment regimen stated in
the FDA & EMA insert leaflets as follows
B. Establishment of Pharmacovigilance system at
these companies and submission of the Phar-
macovigilance System Master File (PSMF).
C. Submission of the Risk Management Plan
(RMP) for this product according to the inno-
vator RMP.
“A Post marketing cohort study should be one
of the Additional Pharmacovigilance activi-
ties of the RMP”.
D. Submission of the Periodic Safety Update Re-
port (PSUR) post registration according to the
EURD (European Union Reference Date) list.
On 08/01/2015
The Technical Committee at CAPA approved the
previously stated Pharmacovigilance requirements
On 05/03/2015
The Pharmacovigilance committee made further
explanation for the required Post marketing co-
hort study as follows:
I. It should include not less than 150 Egyptian
patients in 3 governmental hospitals at least.
II. Use PCR as an efficacy parameter.
III.Monitor the safety and risks (including merg-
ing adverse events) in Egyptian patients.
On 26/03/2015
The technical committee at CAPA decided to ap-
prove the previously stated requirements so that
the study should be conducted over 6 months at 3
university hospitals.
Patient Population Treatment Duration
Patients with
genotype 1, 4, 5or 6
CHC
Sofosbuvir +
Interferon +
Ribavirin
12 Weeks
Post-Marketing Surveillance for Sofosbuvir

5. Pediatric vaccine push with FDA Quadracel nod.
National Organization
for Research &
Control of Biologicals
Post Marketing
Surveillance and
Adverse Event
Following
immunization
Department
Inside this issue:
Pediatric vaccine push with
FDA Quadracel nod.
1
Ebola vaccine based on
current strain looks safe in
PhI.
1
A new diabetes vaccine trial
in children launched.
2
WHO approves a vaccine
for routine infant immuniza-
tion in sub-Saharan Africa.
2
Infant immune systems may
strengthen with HBV expo-
sure.
3
Norovirus candidate vaccine
provokes broad immune
response
3
NORCB Newsletter
Volume 6 , Issue 3March 2015
The French drug maker's new combo
vaccine protects children aged 4 to 6
against diphtheria, tetanus, pertussis
and polio (DTap-IPV), and it could
help them complete the entire schedule
of immunizations with as few injec-
tions as possible, Currently, the CDC
recommends that children in the age
range receive both their fifth dose of
diphtheria, tetanus and acellular pertus-
sis vaccine series and their fourth dose
of inactivated poliovirus vaccine series,
with Quadracel fitting both roles. The
approval was based on data from a
Phase III study designed to compare
the safety and immunogenicity of
Quadracel with separately adminis-
tered DTaP and polio vaccines, The
vaccine already has a green light in
Canada and Australia.
Reference
(Click Here)Fierce vaccines :
Positive results from the Phase I trial
of yet another experimental Ebola vac-
cine are in, but unlike other vaccines
in the field, this one is based on the
virus strain that caused the 2014 epi-
demic, not an older one.
A recombinant adenovirus type-5 vac-
cine was tested in a double-blind, pla-
cebo-controlled trial in Jiangsu Prov-
ince, China, on 120 healthy adults. 40
patients received a low dose and 40
received a high dose, with 95% of the
former group showing a positive im-
mune response, and all 40 of the latter
group exhibiting a response. Those
who received the high dose also made
Ebola vaccine based on current strain looks safe in PhI.
more antibodies than the low-dose
group.
Reference
(Click Here)Fierce vaccines :

6. Volume 6, Issue 3Page 2 Part II NORCB
A new diabetes vaccine trial in children launched.
A Phase II test to see if the prospect can prevent
or delay the onset of Type 1 diabetes in children
at very high risk of presenting with the disease.
For the study, dubbed DiAPREV-IT2, research-
ers have drafted the first participant out of what
will be a group of 80 children in whom the auto-
immune process leading to Type 1 diabetes has
already started. Once enrolled, half the children
will receive two injections , while half will re-
ceive a placebo. Over the 5-year course of the
study, children from either group who develop
symptomatic Type 1 will receive injections after
diagnosis to monitor its effects on new onset pa-
tients,But unlike complementary study Di-
APREV-IT, children participating in DiAPREV
-IT 2 will also receive vitamin D, which the
team hopes will strengthen the vaccine's effica-
cy. In all four of Diamyd's other ongoing studies,
the company has set the jab up as part of combos
that include vitamin D, etanercept, ibuprofen or oth-
er components.
Reference
Fierce vaccines : (Click Here)
WHO approves a vaccine for routine infant immunization in sub-Saharan
Africa.
The affordable meningitis A vaccine has
been given to millions of people in Africa's
so-called "meningitis belt," and is about to be
administered to even more. The World
Health Organization approved the shot, pre-
viously approved for people aged one to 29,
for use in the routine immunization of in-
fants less than one year old in sub-Saharan
Africa. Two companies partnered in 2004 to
develop an affordable vaccine that was tailor
-made for use against meningitis A in sub-
Saharan Africa. According to a WHO re-
lease, the vaccine was developed in record
time and at one-tenth the cost of a typical
new vaccine. It was introduced in Africa in
2010, and since then, more than 215 million
people have been vaccinated in 15
"meningitis-belt" countries. The affected area
stretches from Senegal in the west to Ethio-
pia in the east. The vaccine's efficacy was
confirmed "in a major way" in Chad in 2012. Re-
searchers found that transmission and incidence of
meningitis A had dropped 90% following vaccina-
tion. But while results have been dramatic, there is
still work to be done.
Reference
(Click Here):Fierce vaccines

7. Volume 6, Issue 3Part II NORCBPage 3
Infant immune systems may strengthen with HBV exposure.
A recent study suggests that exposing infants’ im-
mune systems to Hepatitis B Virus Infection (HBV)
increases the maturity of infants’ immune systems,
potentially increasing the chances of infants surviv-
ing bacterial infections throughout early life. These
study results dramatically change how mother-to-
child HBV infections are viewed and may change
treatments given to patients with chronic hepatitis
B. Health professionals previously saw HBV infec-
tious as a way to exploit the immaturity of the in-
fant immune system, which results in a chronic
infection..
Norovirus candidate vaccine provokes broad immune response
Reference
(Click Here)Vaccine news daily :
A new multivalent candidate vaccine has induced
a broad antibody response to a number of strains
of norovirus, even strains that were not included
in the new vaccine or encountered by the subjects
before the study.
The positive results of the study show that there
may be a norovirus vaccine in the future. Typical-
ly noroviruses are elusive to the body’s natural
immune system because the virus escapes using
antigenic drift.
Researchers’ most recent efforts in creating a vac-
cine for norovirus have used virus-like particles
(VLPs) built from molecules taken from the outer
shell, or capsid, of the virus.
“These data reveal new information about com-
plex norovirus immune responses to both natural
exposure and to vaccination, and support the po-
tential feasibility of an efficacious multivalent no-
rovirus VLP vaccine for future use in human pop-
u l a t i o n s , ”
Experts estimate that noroviruses result in one
out of every five cases of viral gastroenteritis. Ap-
proximately 300 million cases of norovirus are
confirmed each year, amounting to approximate-
ly 260,000 deaths. The majority of these cases
and deaths take place in countries with low in-
comes.
Reference
(Click Here):Vaccine news daily

8. A call for reporting
Please remember that you can report suspected adverse
reaction of medicines to EPVC, and adverse reaction
following immunization to NORCB using the follow-
ing communication information
51 Wezaret El Zeraa Street, Agouza, Giza P.O. Box: 354 Dokki
Phone: +202 – 37 480 478 ext. 118
Fax: +202 – 37480472
Email: pmsdep@yahoo.com
National Organization for Research & Control of Biologicals
Post Marketing Surveillance and Adverse Event Following
immunization Department
21 Abd El Aziz Al Soud Street. El-Manial, Cairo, Egypt, PO Box: 11451
Phone: +202 – 23684288,
Fax: +202 – 23610497
Email: pv.center@eda.mohealth.gov.eg
Central Administration of Pharmaceutical Affairs
Egyptian Pharmaceutical Vigilance Center
Pharmacovigilance Department
www.epvc.gov.eg
Communications information
What is Pharmacovigilance
According to the WHO, Pharmacovigilance is
the science and activities relating to the de-
tection, assessment, understanding and pre-
vention of adverse effects or any other medi-
cine-related problem.
What is the Egyptian Pharmaceuti-
cal Vigilance Center
With the increasing demand for patient's
safety which is becoming more stringent, the
regulatory authorities are facing an in-
creased demand for patient welfare and
safety. Thus, The Egyptian Pharmaceutical
Vigilance Center (EPVC) is constructed within
The Central Administration of Pharmaceuti-
cal Affairs (CAPA) Ministry of Health to be
responsible for the collection and evaluation
of information on pharmaceutical products
marketed in Egypt with particular reference
to adverse reactions. Furthermore, EPVC is
taking all appropriate measures to:
1.Encourage physicians and other healthcare
professionals to report the suspected ad-
verse reactions to EPVC.
2.Necessitate the pharmaceutical compa-
nies to systematically collect information
on risks related to their medical products
and to transmit them to EPVC.
3.Provide information to end-users through
adverse drug reaction news bulletins, drug
alerts and seminars.