REGULATION

AND
RESPONSIBILITY
Presented by:
Salazar, Kemuel Jan P.
BPED-3B
 OBJECTIVES
At the end of the lesson, learners should be able to:
1.Identify the regulatory prospective for medicinal product.
2.Acknowledge the regulations of regulations of consumer
products.
3. Enumerate the manufacturer responsibilities.
4.Classify and appreciate the society and policy maker
responsibilities.
 1. REGULATING
MEDICAL PRODUCTS
 MEDICINE
S
• WHO plays a vital role in the regulation of medical products. At
the global level, WHO works to develop internationally recognized
norms, standards and guidelines for medicine quality, safety and
efficacy.
• At the regional level, WHO supports countries in building effective
medicines regulation systems that promote and protect public
health by ensuring certain standards.
 MEDICINE
S
• At the country level, WHO provides guidance, technical assistance
and training to enable countries to implement these guidelines in
the context of their own specific regulatory environment and needs.
At the regional level, WHO supports countries in building effective
medicines regulation systems that promote and protect public
health by ensuring certain standards.
 REGULATIONS OF A MEDICAL
PRODUCT

1. Medicines are of the required quality, safety and efficacy.

2. Medicines are appropriately manufactured, stored, distributed
and dispensed.
3. Illegal manufacturing and trade are detected and adequately
sanctioned.
 REGULATIONS OF A MEDICAL
PRODUCT

4. Health professionals and patients have the necessary information

to enable them to use medicines responsibly.
5. Promotion and advertising are fair, balanced and aimed at
responsible drug use.
6. Unjustified regulatory work does not hinder access to medicines.
As a focal point for the United Nations prequalification programme,
WHO also provides specific technical assistance, and training to
manufacturers and regulators in the WHO European Region to help
them achieve internationally recognized quality standards. The
intention is to give a better understanding of what is required and
why, particularly for medicines for HIV/AIDS, tuberculosis and
malaria; reproductive health products; and neglected diseases. Since
quality systems are built by manufacturers and assessed by national
authorities, the quality of medicines and the capacities of both to
safeguard patient safety should be developed equally.
 MEDICAL
DEVICES
• Regulation is primarily concerned with enabling patient access to
high-quality, safe and effective medical devices, and restricting
access to products that are unsafe or have limited clinical use. When
appropriately implemented, regulation ensures public health benefit
and the safety of patients, health care workers and the community.
 MEDICAL
DEVICES
• WHO has a mandate, as outlined in the World Health Assembly
resolution WHA60.29 to encourage Member States “to draw up
national or regional guidelines for good manufacturing and
regulatory practices, to establish surveillance systems and other
measures to ensure the quality, safety and efficacy of medical
devices.
 2. RULES AND
REGULATIONS FOR
CONSUMER
PROTECTION
• Consumer protection laws exist to prevent dangerous or
unethical business practices, such as false advertising or
faulty products.
• They play an important role in a reliable market economy,
helping to keep sellers honest, with no threat of unpleasant
surprises.
• States use agencies and statutes to enforce consumer
protection and may expand on federal laws, with some
being more pro-consumer than others.
• In legal basis, consumers can file a complaint with the
Department of Trade and Industry (DTI) or the local
consumer affairs office. Documentation, including
communications and proof of purchase, is crucial.
 REPUBLIC ACT NO.7394

• Also known as the Consumer Act of the Philippines, declares that it is

the policy of the State to protect the interests of the consumer, promote
his general welfare and to establish standards of conduct for business
and industry to implement measures to achieve, among others, the
protection against deceptive, unfair and unconscionable sales acts and
practices.
RELATED REPUBLIC ACTS

• Republic Act (RA) 3720 “Foods, Drugs, Medical

Devices
• RA 7394 “Consumers Act.
3. MANUFACTURER
RESPONSIBILITIES
 MANUFACTURER JOB
RESPONSIBILITIES
a. Manufacturers do their work in Manufacturing Company using modern
equipment in order to make the best and quality kind of product. They are the
ones who devoted their time just to fulfill their task in a given time.
b. There are different kinds of procedure that are functioning in the
Manufacturing Company in order to make a new kind of product, and each of
that procedure requires a number of manufacturer in order to assist machine
works as well.
 MANUFACTURER JOB
RESPONSIBILITIES
c. Operating machine properly and accurately.
d. Doing the required task that is given to them.
e. Ensuring quality kind of work while on duty.
f. Take care of any machines that they operate.
g. Take care of the product or item in order to make quality one.
h. Work with harmoniously relationship among their colleagues.
 MANUFACTURER JOB
RESPONSIBILITIES
i. Being punctual at all times.
j. Follow all the rules and regulations imposed by the Manufacturing
Company.
k. Devote them in working in their Company.
l. Keep the confidentiality of their works.
m. Attend meetings and training that are required to attend to.
THANK YOU FOR
LISTENING
ATTENTIVELY!