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 4 April 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:

Volume 6, Issue 4 Page 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.

Volume 6, Issue 4 Page 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:

Volume 6, Issue 4 Page 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

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 3 March 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 :

Volume 6, Issue 3 Page 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

Volume 6, Issue 3 Part II NORCB Page 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

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

Pharmacov ig i l ance Depar tmen t

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.