PAPPIrus Issue 2 September 12, 2008

The recently concluded general mem-bership meeting of PAPPI last May 30, 2008 in Palms Country Club, Alabang was a great success. The meeting was composed of an in-troduction of the Technical Workshop by Ms. Ayie Siscar, an overview of ACTD Require-ments for Drugs by Ms. Alma Aguinaldo and the presentation on Medical Devices by Ms.

Claire Cacanindin.

2008 PAPPI 2nd General Membership Meeting Rio Salas

PAPPI would like to come up with a quick guide manual where all minor and major con-cerns regarding ACTD and applications can be easily found. The manual will greatly helps us in understanding the ASEAN guidelines and having the same understanding with the regu-

lators as well.

One of the most exciting parts of the GMM was the Team Building activity prepared by the scientific committee. PAPPI members in their comfortable attires were divided into 6 groups native games like Patintero, tug-o-war and as usual the cheering of different colors didn’t kept away the crowd from scream of laughter and tease! Cash prizes were given

to the winners.

The Palms Country Club is an addition to the number of our great venues. With its great food selections, fine venue, exciting team building activities and relevant topics made

this GMM a memorable one for me.

Official Newsletter of the

Philippine Association of

Pharmacists in the

Pharmaceutical Industry

The technical workshop was unruffled by the distribution of copies of the ACTD forms and members of PAPPI were grouped into three to be able to list down and tackle all their ques-tions, clarifications on the ACTD forms. Each group made their report after the discussions. The main purpose of this workshop is to be able to raise all the issues and to be able to

submit it to BFAD.

Q&A Portion: ACTD/ACTR

1. ACTD is a

A. Guideline of the agreed common format for the

preparation of well-structured CTD applications.

B. Agreement of the common documents for marketing

authorization in ASEAN plus other countries.

C. Submitted to ASEAN regulatory authorities for the

registration of pharmaceuticals for human use.

D. Only a and b

E. Only a and c

2. Phases of Validation

A. pre-validation phase

B. process validation phase

C. validation maintenance phase

D. all of the above

E. none of the above

3. Certifications: For manufacturing “under license”

A. License of pharmaceutical industries

B. GMP certificate of the manufacturer

C. Contract manufacturing agreement

D. Only a and b

E. Only b and c

4. ACTR contains

A. Stability studies of the drug product

B. BA/BE

C. Manufacturing process

D. Validation procedures

E. All of the above

5. ACTD

A. Part I: Administrative Info and Prescribing Info

B. Part II: Quality

C. Part III: Clinical Document

D. a and b only

E. a, b and c

Answers to Quiz Section

1. E

2. D

3. D

4. E

5. D Public Hearing on IRR of RA No. 9502 Joan Comia and Bibian Dabu

Department of Health held its first public hearing on the Implementing Rules and Regulations of the Universally Accessible Cheaper &

Quality Medicines Act of 2008 with the stakeholders to get suggestions from the medical groups, drug companies, consumers and other

concerned sectors that could be vital to the IRR. DOH Undersecretary Atty. Alex Padilla presided the public hearing. Items discussed are

Chapter 5: Non-Discriminatory Clause Chapter, Chapter 6: Generics Law Amendments, Chapter 7: Pharmacy Law Amendments and others.

(Continued on page 4)

PAPPIrus Page 2

Let Us Remain Committed to our Mission Chat Santos

PAPPI Special Meeting on R.A. 9502 Bibian Dabu and Joan Comia

Our active participation is important to achieve the goals we have set for PAPPI. Each of us has a role to play. Let us support our Officers & Board of Directors, join commit-tees, attend meetings and devote some of our time & tal-ent to fulfill the mission of PAPPI. We must remain commit-ted to our Mission to ensure that everything we do is to-ward that end. As each thinks this way, aware that he/she has an important and necessary role to play, PAPPI

will continue to thrive!

Thank you dear colleagues for your inspiring commitment to PAPPI. God bless us all as we together pursue noble

endeavors!

In our 1st issue of PAPPIrus this year, I asked everyone to

give diligent service, strong commitment and active participation

to PAPPI.

PAPPI will continue to play a vital role in uplifting the function of Pharmacists in the pharmaceutical industry and industries related to medical devices, food, food & nutritional supplements, cos-metics and veterinary products by coming up with relevant train-ing programs and activities to enhance the competencies of its members. PAPPI will also be continuously regarded as an indis-pensable partner in the industry we operate, the Regulatory Au-thorities and other key stakeholders. PAPPI will inevitably contin-ue to face challenges but as a strong organization, it will evolve as a successful contributor in finding the best solutions because of

committed members.

Last 11 July 2008, PAPPI called for a Special Meeting to tackle looming issues concerning Republic Act No. 9502 also known as “ Universally Accessible Cheaper and Quality Medicine Act of 20008”. This special meeting was held in Bayanihan Hall of United

Laboratories through the kind effort of our esteemed colleague Ms. Malou Garganera. Atty. Froilan Bagabaldo, Vice President of the

Philippine Pharmacists Association (PPHA) was invited as guest speaker.

While this Act was already signed by the President, appeals and further clarifications on issues which bears effect R.A. 8293 – Intel-lectual Property Code of the Phils., Drugs and Medicines Price Regulation, R.A. 6675 – Generics Act of 1988, R.A. 5921 – Pharmacy

Law and the Non-discriminatory Clause, still arises from the pharmaceutical industry.

Be as it way, there is still an opportunity to incorporate designed specific details, as drafting of the Implementing Rules and Regula-tions (IRR) is still on going. As a pharmacist and PAPPI member, let us be vigilant and proactive in participating in the drafting of the

IRR.

As such, we are encouraged to be passionate with the commitment in delivering better service to our countrymen by not going way-

ward to our sworn oaths. Be involved in every step of the Implementing Rules and Regulations.

Page 3 Issue 2

ACCSQ - Drugs

8th ACCSQ-MDPWG in Bali, Indonesia Jennifer Concepcion

The 8th meeting of the ACCSQ-MDPWG Meeting was held last July 14-17, 2008 in Bali, Indonesia. This was organized by the Ministry of Health-Indonesia in collaboration with GAKESLAB,

the Indonesian association of medical device companies.

July 14 marked the first meeting of the Medical Device Technical Committee (MDTC) headed by Dr. T. Bahdar J. Hamid from the Ministry of Health-Indonesia. The meeting was solely attended by coun-

try regulators to discuss mainly the draft of the ASEAN Medical Device Directive (ASEAN MDD).

A one-day workshop on July 15 preceded the two-day MDPWG meeting. Topics presented were: Common Submission Dossiers Template (CSDT), Risk Assessment and Risk Management, Quality Man-agement System and Auditing and Good Distribution Practices. During the panel discussion, Boston Scientific Philippines being one of the panelists presented in brief the experiences of the local de-

vice industry during the CSDT pilot study conducted by the Bureau of Health Devices and Technolo-

gy (BHDT).

The MDPWG meeting was chaired by Mr. Ahmad Bin Mahmud from the Medical Device Bureau of the Ministry of Health-Malaysia and co-chaired by Mr. Alfred Kwek from the Health Sciences Authority- Singapore. The meeting was attended by delegates from Brunei Darrusalam, Cambodia, Indonesia, Lao PDR, Malaysia, Philippines, Thailand, Singapore, Vietnam and representatives from

ASEAN Secretariat. Observers from China, Hongkong, Australia and USA were also present in the meeting.

The ASEAN Secretariat presented the highlights from the 31st ACCSQ meeting, the update on latest development on ASEAN eco-nomic integration as well as the update on the status of the technical assistance and cooperation with dialogue partners. The CSDT implementation, IVD classification and Global Medical Device Nomenclature (GMDN) were discussed by Singapore. Indonesia up-dated the committee with the outcome of the 1ST MDTC meeting and the 1st draft of the ASEAN MDD. Malaysia presented the for-malization of the Post-Marketing Alert System (PMAS) for defective and unsafe medical devices. The elected Chairman of the ASEAN Medical Device Industry Association (AMDIA) presented the final draft of the Terms of Reference and the status of its estab-

lishment.

The 9TH meeting will be held on January 2009 in Malaysia.

The Bureau of Food and Drugs conducted a two day training on Parts I and II of the ASEAN Harmonized Common Technical Document and Requirement last July 23 to 25, 2008. The training’s main objective is to ensure the clarity and uni-formity of implementation to comply with the Philippine timelines and commitment to fully implement the ASEAN Harmonized documents by the end of December

2008.

Participants were members from various sectors of the Pharmaceutical Industry. Although PAPPI was represented by Carmela Abulencia, Liezl Jacinto, Juliet Man-rique, Noemi Natividad and Josephine del Parto, many participants from other associations were also PAPPI members. Resource speakers and key persons from the Bureau shared their knowledge to help the industry understand the require-ments of the ACTD/ACTR. The training also served as a perfect venue both for the regulators and the industry to discuss and clarify issues that will be helpful in the full implementation of the ASEAN Harmonized Technical Document and Require-

ment.

The training was the first of its kind as a part of BFAD’s endeavor to help and pre-pare the industry for the full implementation of the ASEAN Harmonization by

1. Wilhelmina Isidro

Ajanta Pharma Phils, Inc

2. Czarina Leah Evangelista

Ajanta Pharma Phils, Inc

3. Anna Leah Remandas

B. Braun Avitum, Phils, Inc

4. Jerome Ramos

Britton Distributions, Inc

5. Carmina Regudo

Brown and Burk Phils, Inc

6. Julie Anne Odarbe

Croma Medic Inc

7. Remigio Acosta

Croma Medic Inc

8. Christine Ivy Peralta

Croma Medic Inc

9. Minerva Lucas

Daewong Pharma Phils

10. Alfredo So

GSK Consumer

11. Lucy Romero

Reckitt Benckiser Healthcare Phils,Inc

12. Shemaine Castillo

Roche Phils, Inc

13. Cherry Ann Mendoza

Sandoz Corp

14. Paul Bernard Ibe

Sanofi Pasteur, Inc

15. Carolina Guinto

Speed Com Distribution, Inc

MEMBERS For Induction

2nd GMM - Sep. 12, 2008 BIRTHDAY CELEBRANTS

JULY

Training on the ACTD/ACTR

on Pharmaceutical Registration for Human Use Noemi Natividad

EDITORIAL STAFF

Editor-In-Chief

RIO SALAS

Layout Artist

JERVIN PAPELLERAS

Contributors

BIBIAN DABU

JOAN COMIA

JENNIFER CONCEPCION

MALOU GARGANERA

LIEZL JACINTO

RIO SALAS

CHAT SANTOS

NOEMI NATIVIDAD

Special Thanks to

CHARITY BOX

MINETTE FARINAS

CARLO ULEP

GRACE VALENCIA

Adviser

BABETTE DELA ROSA

7 Lousene Rodriguez

7 Winnie Isidro

8 Jules Odarbe

8 Eileen Tantingco

15 Anche Leh

16 Bubbles Barredo

18 Char Cordova

19 Mitch Mendador

21 Lychee Jacinto

24 Cherry Mendoza

25 Babette dela Rosa

27 Jasmin Sy

31 Gene Zurbano

AUGUST

2 Regie Cabangcala

4 Emily De Jesus

5 Rosanne Mones

8 Remigio Acosta III

11 Josel Mendoza

13 Grace Castillo

14 Jojie Lim

15 Siony Sayson

18 Lyn Baldric

18 Bong Laforteza

19 Beth Manansala

20 Anna Leah Remandas

21 Sweeden de Jesus

24 Ginalyn Verzano

30 Beth Javellana

SEPTEMBER

1 Miel Abulencia

3 Dearly Velasco

4 Joan Naguit

8 Jaclyn Rivera

8 Lani Gudani

9 Lucienne Avelino

11 Anna Navata

15 Dolly Lafradez

15 Roxanne Macuha

15 Shemaine Castillo

16 Alma Aguinaldo

20 Elma Fajardo

20 Dianne Santos

20 Gia de Guzman

22 There Gatiera

26 Juliet Manrique

26 Rheb Camus

26 Gail Dela Cruz

1 Girlie Malamug

8 Marvin Malonzo

9 Raquel Soliven

11 Carol Guinto

14 Avic Besa

14 Neneth Calalang

16 Gigi Castaniaga

16 Lizette Jamito

16 Jaymie Gulle

16 Alyson Batacan

19 Dixie Calpatura

24 Charity

24 Meng Cunanan

25 Rio Salas

26 Tina Aguilar

26 Rachel Redobla

30 Jairus Garcia

31 Anna Dimalanta

OCTOBER

2 Mercy Bondad

3 Ruth Miranda

3 Philip Palo

4 Vilma de Luna

10 Janice Rico

11 Marivic Gonzales

16 Gigi Nievales

16 Sherica Sy

20 Love Taganas

24 Ann Andaluz

NOVEMBER

1 Minerva Lucas

2 Bibian Dabu

5 Beth Escueta

7 Karen Dabuet

8 Susan Florentino

8 Ching Cayabyab

11 Alfred So

11 Jamie Lee

13 Chat Santos

14 Christine Panghulan

17 Czarina Evangelista

18 Ruthie Talusan

20 Claire Cacanindin

21 Debbie Bajar

26 Kharoll Tobias

27 Mayette Razon

DECEMBER

Public Hearing on IRR (continuation)

Among the concerns aired include the requirement for drug outlets to “carry” certain medicine and drugs imported by the

government, amendment of the Generics Law with the provision that requires pharmaceutical companies to manufacture a

generic version of their products and amendment of the Intellectual Property Law that allows to do parallel importation

pursuant to internationally-agreed flexibility.

Under the law, the government is mandated to come out with the IRR within a 120-day period or until Nov. 4. The

countdown started last July 4. Second public hearing is set on September 5, 2008.